Category: 3. Business

Ferrari has cut the number of cars it sells in the UK as wealthy individuals relocate overseas after tax changes and the abolition of non-dom status.

The Italian luxury carmaker reportedly began limiting the number of vehicles it exported to the UK about six months ago, in an attempt to stop a decline in their residual value.

Benedetto Vigna, the chief executive of the carmaker, said that Ferrari had seen a “stabilisation” in sales after the decision to reduce the number of vehicles it allocated to the UK.

“Some people are getting out of that country for tax reasons,” he told the Financial Times, adding that taxes were not the only reason for the fall in residual values. “There are many different factors. Maybe when you sell to the UK, that car cannot be sold somewhere else [because of its right-hand wheel]”.

In April the government abolished favourable tax treatment for non-domiciled residents – UK residents who declared that their long-term home was overseas to avoid paying UK taxes on global income and assets – and raised other duties on the wealthy.

The chancellor, Rachel Reeves, told the Guardian earlier this week that talk of an exodus of wealthy residents was just “scaremongering”.

“This is a brilliant country and people want to live here,” she said. “And I think, when people scaremonger again this year, we should take some of that with a pinch of salt.”

Reeves, who has said that the wealthy will be one of the targets for higher taxes in next month’s budget, has previously ruled out imposing a “wealth tax” but campaigners for changes to the system have highlighted other options.

These include raising the rate of capital gains tax, levying national insurance on rental income and on partners in law firms and consultancies, and creating higher council tax bands.

The non-dom tax changes sparked fears that Ferrari would lose its wealthy client base, leading to volatility in its residual prices, or the expected secondhand value of a vehicle when a leasing deal comes to an end.

Most new cars in developed markets are bought on deals that provide financing based on the amount of value a vehicle loses – its “depreciation” – rather than the overall sticker price.

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If cars have weaker secondhand prices, the financing needed increases and the car becomes more expensive to lease.

The residual value for Ferrari’s Purosangue model fell 12.2% between January and October, while the SF90 Stradale fell 6.6%, according to AutoTrader.

However, prices have started to stabilise in recent months. The Ferrari 296 GTB, a supercar launched in 2022, had a recommended retail price from £256,275 if bought new. However, a used version was available from £189,490 on AutoTrader.

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Novo Nordisk shares fell on Friday after Donald Trump vowed to sharply lower the price of its popular weight loss drug Ozempic as part of the US president’s drive to cut the price of medicines in America.

Speaking at a press conference on Thursday, Trump said Ozempic’s price would be “much lower” once his administration had concluded negotiations with Novo Nordisk, the Danish group that pioneered obesity drugs.

Trump suggested the price of the drug could fall to as low as $150. Novo Nordisk halved the US price of Ozempic for people who cannot access it with health insurance to $499 earlier this year.

Shares in the Danish pharma group fell 5 per cent in early trading in Copenhagen on Friday. Shares in US pharma group Eli Lilly, its major rival in the obesity market, dropped 5 per cent in after-hours trading in New York.

US patients have historically paid much higher prices for drugs than their peers in other industrialised countries. Since returning to the White House, Trump has pushed drugmakers to lower prices for American consumers, threatening import tariffs if they do not agree.

He has complained that anti-obesity drugs are available in the UK at a fraction of their cost in the US, where branded medicines are on average two to three times more expensive than they are in Europe.

Last month, Pfizer reached a deal with the Trump administration to lower the prices of some drugs. Eli Lilly has been widely expected to reach a deal with the White House but has yet to do so.

Speaking alongside Trump at an event announcing a deal to lower costs of IVF treatment, Mehmet Oz, the head of the Centers for Medicare & Medicaid Services, said negotiations with Novo Nordisk were ongoing.

“We have not negotiated those yet . . . the President will be happy with the results, and until he is we are not going to close those negotiations,” he said.

Novo said it had “engaged in discussions” with the White House and remained “focused on improving patient access and affordability”.

Eli Lilly has been contacted for comment.

This September, Carlsberg Asia and Grab marked the second year of their partnership – a collaboration that is transforming how consumers across Southeast Asia enjoy beer responsibly

Launched in late 2024, the partnership connects Carlsberg’s premium beer experiences with Grab’s vast digital ecosystem, from mobility and food delivery to dine-out offers, embedding responsible drinking messages into everyday moments.

This strategic partnership has already yielded significant results. From January to August 2025, there has been a 37% increase in average new Carlsberg consumers per month within the Grab ecosystem (vs. same period in 2024), 22% year-on-year growth in user numbers and average uplift of 49% in Carlsberg sales, marking a 35% year-on-year increase in overall sales.

Anchored in Carlsberg’s long-standing partnership with Liverpool F.C., the longest-running partnership in Premier League history since 1992, the collaboration has turned key football occasions into moments that combine celebration and moderation. In Singapore, the campaign culminated in September with the ‘Champion EPL Season with Carlsberg’ event, featuring Liverpool legend Robbie Fowler. Fowler toured Grab’s headquarters, rode through Orchard Road and the Civic District on an open-top bus, and met with fans, media, and VIP guests, celebrating the partnership’s success and reinforcing the message of responsible enjoyment.

Events across Malaysia, Cambodia, Myanmar, and Singapore brought fans together both online and offline, while in-app activations on Grab offered prizes like match tickets, retro jerseys, and ride discounts promoting safe mobility.

Following these successes, the next phase of the campaign will roll out in Vietnam later in 2025.

“Our partnership with Grab is a powerful expression of Carlsberg’s Accelerate SAIL strategy in action,” says Arindam Varanasi, Commercial VP, Carlsberg Asia. “By combining Carlsberg’s brand strength with Grab’s reach, we’re shaping a culture where enjoyment and mindful consumption go hand in hand.”

Through Grab’s ecosystem, including GrabFood, GrabMart, Dine Out, and mobility services, Carlsberg can reach consumers across multiple occasions, linking celebration with safety and convenience.

The partnership will continue to expand in Vietnam and beyond later this year, building on its success to make responsible drinking a natural part of how people connect, celebrate, and enjoy life across Asia.

As Jim Chalmers moves among the global elite during the G20 talkfest with fellow finance ministers and big-time investors in Washington this week, he will be spruiking Australia’s enviable economic performance over recent years.

A particular point of pride has been the strength of the labour market.

Not only has unemployment stayed low, the increase in the share of working-age Australians with a job has climbed by 3.1 percentage points since immediately before the pandemic.

That increase is twice the OECD average, and compares with zero growth in the US and New Zealand. In Canada and the UK, the employment rates have dropped by 0.4 and 1.1 percentage points, respectively.

Chart showing recent changes in labour market in Australia and other countries

That performance, however, was cast under a cloud this week, after the unemployment rate unexpectedly jumped to 4.5% – its highest level in nearly four years.

After dropping to nearly 50-year lows of 3.4% in late 2022, the Reserve Bank of Australia and Treasury had both expected this rising trend to stop at about 4.3%.

The AMP chief economist, Shane Oliver, says that the jobless rate is “in a clear rising trend”.

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The RBA board has made it clear it is holding fire on further rate cuts until it is more confident that inflation continued to ease through the September quarter. But the latest labour data has complicated the issue.

“A further rise beyond this would arguably be violating the RBA’s full employment objective,” Oliver says.

“Of course, the rise in unemployment may just reflect the lagged impact of weak economic growth last year, but it may also reflect a messy handover from the public sector to the private sector as the key driver of jobs.”

This “messy” handover is what has experts worried.

Big increases in federal funding for the care economy – from aged care, to childcare and health more broadly – flowed through to a surge in hiring that accounted for a lion’s share of the more than 1 million jobs created since Labor took office in 2022.

In the 2023 and 2024 calendar years, around 80-90% of the rise in employment was in these so-called “non-market” segments, or heavily taxpayer-subsidised industries.

Graph showing different economic sectors’ contributions to employment growth over the past 2 years

That’s not to denigrate the roles.

As Chalmers has been quick to point out, “they are real jobs”.

“They look like real jobs to me, looking after older people and people in the NDIS and early childhood education,” he said last month.

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But this dynamic is key to understanding why employment could continue to boom even as the economy virtually stagnated.

Now we have, as Oliver says, the “messy handover”, as the private sector attempts to pick up the hiring slack.

Pat Bustamante, an economist at Westpac, calculates unemployment could push towards 4.8% in early 2026 if the private sector does not grow fast enough to replace the slower growth in government spending.

Which way it goes from here remains highly uncertain, and economists now see a real chance the RBA feels the need to deliver an interest rate cut at its Melbourne Cup day meeting.

Not everyone is convinced the jobs market is about to head south, or that the central bank will rush to cut rates again.

Jonathan Kearns is chief economist at Challenger and a former senior RBA official.

Kearns reckons people and investors have overreacted to one bad employment number.

Employment climbed in September, he says, just not quite as much as expected, which, when combined with an influx of new jobseekers, pushed up the jobless measure.

That could easily reverse in October, and the RBA board is likely to remain fixed on the “critical” quarterly inflation figure on 29 October.

“Things have been too easy,” Kearns says. “Inflation came down faster than expected and unemployment didn’t rise as much as anticipated. Things looked amazingly good, and you are always going to hit some bumps in the road.”

Patrick Commins is Guardian Australia’s economics editor

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Yara reports third quarter 2025 EBITDA excluding special items¹ of USD 804 million compared with USD 585 million in second quarter 2024. Net income was USD 320 million compared with USD 286 million a year earlier.

Third quarter 2025 highlights:

• EBITDA excl. special items¹ of 804 MUSD, up 38% from 3Q24
• Increasing returns through continued improvement focus and cost reductions, supported by favorable market conditions
• Record high production² and strong commercial performance
• YTD 2025 adjusted earnings per share³ at 3.25 USD – up from 1.37 USD last year

“Our continuous focus on improvement is delivering solid results, and we are pleased to report another strong operational quarter. This quarter’s performance reflects higher margins, strong commercial execution, and record-breaking production levels for the third consecutive quarter. In parallel, we are ahead of schedule in our cost reduction program, further strengthening our returns,” said Svein Tore Holsether, President and Chief Executive Officer.

Yara makes progress on the improvement agenda to strengthen financial returns by driving sustainable profitability in core operations and pursuing value-accretive growth, supported by strict capital discipline. The group is prioritizing cash conversion by allocating resources to high-return core assets while scaling back non-core and lower-yield activities, ensuring increased capital productivity.

With the combination of cost reduction, portfolio optimization and a tightening nitrogen market, Yara’s financial position is set to strengthen with increased free cash flow and sustainable profitability. Net income year-to-date 2025 is USD 1,028 million, up from USD 306 million in 2024. While this is supported by a non-cash net foreign currency gain of USD 386 million, it also clearly demonstrates that Yara’s improvement focus yields increased results. This will enable improved shareholder returns through cash distributions and re-investment in value-accretive growth opportunities subject to double digit returns – such as renewing our ammonia portfolio by accessing low-cost ammonia through potential equity positions the US ammonia projects.  

Link to report, presentation, and webcast on 17th October 2025, at 12:00 CEST:
https://www.yara.com/investor-relations/latest-quarterly-report/

1) For definition and reconciliation see APM section in the 3Q report, pages 22-29. 
2) YIP production performance adjusted for portfolio optimization.
3) Adjusted basic earnings/(loss) per share excl. foreign currency exchange gain/(loss) and special items. For definition and reconciliation see APM section in the 3Q report, pages 22-29.

Contact
Maria Gabrielsen
Head of Investor Relations
M: +47 920 900 93
E: maria.gabrielsen@yara.com

Tonje Næss
Head of External Communications
M: +47 408 446 47
E: tonje.nass@yara.com  

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act. This stock exchange announcement was published by Maria Gabrielsen, Head of Investor Relations, at Yara International ASA, on 17th October 2025 at 08:00 CEST.

About Yara

Yara’s mission is to responsibly feed the world and protect the planet. We pursue a strategy of sustainable value growth through reducing emissions from crop nutrition production and developing low-emission energy solutions. Yara’s ambition is focused on growing a nature-positive food future that creates value for our customers, shareholders and society at large and delivers a more sustainable food value chain.

To drive the green shift in fertilizer production, shipping, and other energy intensive industries, Yara will produce ammonia with significantly lower emissions. We provide digital tools for precision farming and work closely with partners at all levels of the food value chain to share knowledge and promote more efficient and sustainable solutions.

Founded in 1905 to solve the emerging famine in Europe, Yara has established a unique position as the industry’s only global crop nutrition company. With 17,000 employees and operations in more than 60 countries, sustainability is an integral part of our business model. In 2024, Yara reported revenues of USD 13.9 billion.

www.yara.com  

This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act
 

The headlong rush to build huge new datacenters, in order to support the growth of AI, is raising a number of concerns in the US – around the impact upon the climate crisis, water use and electricity bills. It’s also set to reshape American politics in potentially unusual ways.

Companies such as Microsoft, Google, OpenAI, Amazon and Meta are pouring hundreds of billions of dollars into new datacenters that will form the backbone to the surging use of AI by businesses and the public.

This frenzy of building means that datacenters could account for more than 14% of the US’s total power demand by 2030, triple the amount it does now. Utilities predict that the same volume of electricity it would take to power six cities will be required just to keep data centers online by this time.

More, after this week’s most important reads.

Essential reads

In focus

“Meeting this demand will require considerably more electricity than is currently produced in the United States,” a recent report by McKinsey acknowledged of the new thirst for datacenters. “This spike in electricity needs is unprecedented.”

So where will this new power come from? Under Donald Trump’s vision, it will be from fossil fuels, not the wind turbines and solar panels the president disparages as “garbage” and unwanted in the US.

Trump has championed the growth of AI and sought to tear down environmental regulations that can slow the building of datacenters and the gas and coal plants that could power them. Forecasts for coal generation, which has been sliding for years in the US, have ticked up recently amid the AI boom and promises of direct subsidies from the Trump administration.

Clean energy does continue to grow in the US and datacenters could become more efficient over time. But the AI explosion carries a hefty climate risk if it remains hooked to fossil fuels – the International Energy Agency has warned that the amount of planet-heating gases from power plants that run datacenters could double by 2035.

For most Americans, though, there are more pressing worries that come with the new datacenters. As new facilities have sprouted in places like Virginia – which now has a region called “datacenter alley” – and in Texas, people have started voicing concerns about the billions of gallons of water they are sucking up to cool their computer hardware.

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Households are also facing steeper bills to fund the new power generation and transmission projects needed for datacenters – electricity costs could rise by an average of 8% nationally in the next five years because of this, recent analysis has found.

Amid existing alarm over inflation, this sort of trend is unnerving to politicians of all stripes. Both Republican and Democratic leaning voters have expressed opposition to datacenters, making it risky for those running in certain congressional districts to echo Trump’s enthusiastic support for them.

If the datacenter boom is to be curbed then cost of living woes, rather than the climate crisis, will likely be the telling factor.

Read more:

The €391 million contemplated transaction would reinforce the Group’s commitment to core telecom infrastructure assets

Barcelona, 17 October 2025 – Cellnex, through its wholly owned subsidiary Cellnex France, S.A.S., has entered into a put option agreement with Vauban Infra Fibre (VIF) by virtue of which Cellnex France S.A.S can sell 99.99% of the share capital of Towerlink France, S.A.S., the entity responsible for the Group’s main data center operations in France.

VIF is a French company backed by funds from Vauban Infrastructure Partners, entities of Crédit Agricole Assurances, and Raffles, a subsidiary of GIC, with a strong presence across multiple sites in France, many of which are already operational.

The contemplated transaction, valued at €391 million, would be settled entirely in cash and is subject to the information and consultation process with employee representative bodies in France, in accordance with applicable regulations. In addition, final closing would remain contingent upon the fulfillment of customary conditions for transactions of this nature, including regulatory approvals and standard contractual requirements.

This contemplated divestment aligns with Cellnex’s strategic roadmap and will allow the Group to continue focusing on its core areas of activity.

“We remain committed to operational excellence and disciplined capital allocation, always with the objective of delivering sustainable growth and long-term value for our shareholders” stated Marco Patuano, CEO of Cellnex.

For its part, Steve Ledoux, CEO of VIF (Vauban Infra Fibre), the acquiring entity, commented: “VIF is pleased to negotiate this investment in line with our investment strategy. Towerlink will thrive within VIF by continuing to deliver our common ambition and accelerate our development in the data centre market and by implementing attractive synergies with other French data centres and digital assets of the portfolio. We look forward to supporting the company in deploying a high quality portfolio of assets throughout France.” 

Cellnex is advised by BBVA and CACIB as M&A advisor, HSFK as legal advisor and tax advisor and Analysys Mason as commercial advisor.

 

About Cellnex

Cellnex is Europe’s largest telecommunications towers and infrastructures operator, enabling operators to access a wide network of telecommunications infrastructures on a shared-use basis, and thus helping to reduce access barriers and to improve services in the most remote areas, whilst also contributing to more sustainable deployment. The Company manages a portfolio of more than 110,000 sites, including forecast roll-outs up to 2030, in 10 European countries, with a significant footprint in Spain, France, the United Kingdom, Italy and Poland. Cellnex, which is listed on the Spanish Stock Exchange, is part of the selective IBEX35 and Euro Stoxx 100 and enjoys outstanding positions on the main sustainability indexes such as FTSE4Good, MSCI and DJSI Europe.

At first glance, moving from a diesel vehicle to an electric one didn’t look economically viable. The biggest learning from this project was that it required long-term planning.

It has always been clear to us that this pilot was not a standalone project. It’s the start of a longer-term strategy we have been building – a strategy to ensure cost efficiencies, lower GHG emissions and reduce waste.

• YUFLYMA^® (adalimumab-aaty), and its unbranded version, are now approved for two additional pediatric indications – adolescent hidradenitis suppurativa (HS) and pediatric uveitis (UV), in the U.S. ^{[1] , [2]}
• Pediatric UV is a rare eye inflammation in children, representing 5–10% of all uveitis cases in the U.S., while HS affects approximately 1–4% of the U.S. population ^{[3] , [4]}
• Celltrion strengthens and expands its biosimilars immunology portfolio in the U.S., advancing affordable treatment options for patients living with chronic immune-mediated diseases

INCHEON, South Korea, Oct. 17, 2025 /PRNewswire/ — Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA^® (adalimumab-aaty) and its unbranded version, to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.^[1],[2]

The FDA previously approved YUFLYMA as a biosimilar to Humira^® for a variety of indications, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps). HS and UV were previously approved in adult patients, and the latest approval expands these two indications to include pediatric and adolescent populations.^[1]

HS, which affects approximately 1%-4% of people in the U.S., is a chronic, inflammatory, recurrent skin condition characterized by painful nodules, abscesses, comedones, fistulas, sinus tracts, and scarring in intertriginous areas. Adolescent HS shares similar clinical features and often disrupts school and daily life. Pediatric UV, a potentially sight-threatening eye condition that accounts for 5-10% of all uveitis cases, is frequently asymptomatic in children and can become chronic or may have significant morbidities in pediatric patients, such as cataract, glaucoma, and amblyopia.^[5],[6]

“Adolescent HS and pediatric UV are chronic inflammatory conditions that can have serious sequelae and place a significant burden on patients, their families, and caregivers. It impacts patients physically and also emotionally and socially,” said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. “With this label expansion, YUFLYMA is now able to provide treatment options for more patient populations, further supporting broader access for both patients and physicians.”

YUFLYLMA was first introduced in the U.S. market in July 2023 and is currently available as 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg solution for injection in autoinjectors. Celltrion offers adalimumab-aaty in both branded and unbranded versions, with two pricing options to meet differing patient needs and improve patient affordability.

“The expansion of pediatric indications for YUFLYMA highlights our commitment to addressing unmet needs in both adult and pediatric immune-mediated diseases,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “The approval of pediatric indications for YUFLYMA and unbranded adalimumab-aaty strengthens our growing immunology portfolio and supports broader patient access to high-quality, affordable treatments.”

###

Notes to Editors:

About YUFLYMA ^®  (CT-P17, biosimilar adalimumab-aaty) ^[1] 

YUFLYMA^® is a high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval. YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. YUFLYMA has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe and autoinjector. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is available in prefilled syringe as 20mg/0.2mL, 40mg/0.4mL and 80mg/0.8mL and autoinjector as 40mg/0.4mL and 80mg/0.8mL. Additionally, YUFLYMA features one of the longest shelf lives in its class, maintaining stability at room temperature (77 °F, 25 °C) for up to 31 days.

IMPORTANT SAFETY INFORMATION ^[1] 
This important safety information also applies to YUFLYMA ^®  (adalimumab-aaty).

SERIOUS INFECTIONS

Patients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use.
  
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  
• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection.

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

• Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections.
• Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.
• Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty with other biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

• Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy.
• In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients.
• NMSC was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS, HS and UV, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of psoralen + ultraviolet light A (PUVA) treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty.
• In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers.
• Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents.

HYPERSENSITIVITY

• Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

• Use of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.
• Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
• Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.
• In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely.

NEUROLOGIC REACTIONS

• Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
• Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop.
• There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

• Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents.
• Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.
• Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities.

HEART FAILURE

• Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.
• Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully.

AUTOIMMUNITY

• Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment.

IMMUNIZATIONS

• Patients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines.
• It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy.
• No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.
• The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

• The most common adverse reactions in adalimumab clinical trials (>10%) were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

INDICATIONS

Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for:

• Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA
• Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older
• Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
• Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS
• Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older
• Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers
• Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate
• Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older
• Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult and pediatric patients 2 years of age and older

For Yuflyma (adalimumab-aaty): Please click for Full U.S. Prescribing Information.

For adalimumab-aaty: Please see Full U.S. Prescribing Information.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About Celltrion, Inc. 

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media – LinkedIn, Instagram, X, and Facebook.

About Celltrion USA 

Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion’s FDA-approved biosimilar products in immunology, oncology, hematology,  endocrinology and ophthalmology include: INFLECTRA^® (infliximab-dyyb), TRUXIMA^® (rituximab-abbs), HERZUMA^® (trastuzumab-pkrb), VEGZELMA^® (bevacizumab-adcd), YUFLYMA^®(adalimumab-aaty), AVTOZMA^® (tocilizumab-anho), STEQEYMA^® (ustekinumab-stba) STOBOCLO^® (denosumab-bmwo), OSENVELT^® (denosumab-bmwo), OMLYCLO^® (omalizumab-igec), and EYDENZELT^® (aflibercept-boav), as well as the novel biologic ZYMFENTRA^® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media – LinkedIn.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as “prepares”, “hopes to”, “upcoming”, “plans to”, “aims to”, “to be launched”, “is preparing”, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, “anticipates”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries’ management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company’s business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.

Trademarks

Humira is a registered trademark of AbbVie.

YUFLYMA^® is a registered trademark of Celltrion, Inc., used under license.

References

For further information please contact:
Katie Gallagher
[email protected]
+1 617-657-1324

SOURCE Celltrion USA