The company has gone ahead and bought the commercial rights for Byooviz from Biogen, and the product is now going to be available as a brand from Samsung Bioepis throughout many European countries as part of the ongoing expansion plans that it has.

It was in August 2021 that Byooviz went on to receive an approval from the European Commission – EC as a single-use vial when it comes to intravitreal administration – 0.5mg/0.05ml.

It is indicated for treatment in terms of visual impairment because of diabetic macular oedema, neovascular – wet age-related macular degeneration, visual impairment due to choroidal neovascularization, and proliferative diabetic retinopathy, as well as visual impairment because of macular oedema secondary to retinal vein occlusion – branch or central.

The Committee for Medicinal Products for Human Use – CHMP of the European Medicines Agency – EMA issued quite a positive opinion for the Byooviz pre-filled syringe – PFS in November 2025. The syringe is expected to enter the European market sometime in the second quarter of 2026.

Antonio Rito, the vice-president of Samsung Bioepis said that direct commercialization of Byooviz indeed a major milestone for Samsung Bioepis since the company continues to make its presence across Europe very robust through expanding its portfolio when it comes to directly commercialized products.

He added that making utmost use of the last three years of experience with Epysqli – eculizumab and the newly launched Obodence – denosumab along with Xbryk – denosumab in Europe, they are going to continue with their journey to become a completely integrated biopharmaceutical company having end-to-end capabilities right from development to commercialization.

They are going to work closely along with payers as well as healthcare professionals in order to make sure of a seamless access when it comes to their biosimilar medicines for patients who are in need.

In September 2023, Sandoz went on to collaborate with Samsung Bioepis in order to develop and also market a Stelara – ustekinumab, a biosimilar in the US, Canada, and Europe.

• The UK secured exclusive zero percent tariff access for pharmaceuticals entering the US, removing a major source of trade uncertainty.
  
• The revised NICE threshold reshapes the UK’s health-technology assessment model and widens the path for higher-value medicines to reach the NHS.
  
• The bilateral deal signals US expectations for greater UK spending on innovative treatments, aligning commercial incentives with expanded patient access.

The United States and the United Kingdom have announced a historic agreement that eliminates tariffs on all UK pharmaceutical exports to the American market for a minimum of three years, marking a significant shift in transatlantic pharmaceutical trade dynamics. The US and UK zero tariff deal represents the culmination of months of intensive negotiations and comes as the Trump administration continues to reshape global pharmaceutical pricing frameworks.​

Under the agreement, UK-origin pharmaceuticals, pharmaceutical ingredients, and medical technology products will be completely exempt from Section 232 tariffs and will not be targeted under any future Section 301 investigations for the duration of President Trump’s term. In exchange, the United Kingdom has committed to substantial reforms to its pharmaceutical pricing framework that will increase patient access to innovative treatments.​

The UK’s Commitments

The centerpiece of the UK’s commitments involves a significant restructuring of how the National Health Service evaluates and pays for new medicines. The net price for new pharmaceutical treatments will increase by approximately 25 percent, marking the first major increase in NHS spending on innovative medicines in over two decades. Additionally, the rebate rate under the Voluntary Scheme for Branded Medicines Pricing, Access and Growth will be reduced to 15 percent by 2026 and maintained at that level throughout the agreement’s duration.​

These reforms are designed to accelerate patient access to breakthrough therapies that may have previously been deemed too costly for NHS approval. Healthcare professionals and patient advocacy groups have welcomed the provision, which promises to bring cutting-edge treatments to the NHS patient base more rapidly.​

Strategic Significance for the Industry

The agreement arrives at a critical juncture for the UK life sciences sector. Major pharmaceutical companies, including MSD and AstraZeneca, had postponed or canceled significant investment plans in the UK, citing an inhospitable business environment. This deal explicitly aims to reverse that trend by providing tariff certainty and improving the conditions for pharmaceutical manufacturing and research operations within the UK.​

The UK becomes the only country globally to secure zero percent tariffs on pharmaceutical exports to the United States, positioning it with a distinct competitive advantage against other pharmaceutical manufacturing hubs competing for investment.​

US Administration Perspective

From the American perspective, Health and Human Services Secretary Robert F. Kennedy Jr. framed the agreement as bringing long-overdue balance to US-UK pharmaceutical trade, asserting that Americans should not bear disproportionate drug costs. The administration views the US and UK zero tariff deal as part of a broader effort to ensure that developed nations contribute fairly to the costs of pharmaceutical innovation.​

• EC approval of Gobivaz gives Alvotech and Advanz Pharma a stronger foothold in Europe’s competitive biosimilar segment.
• The authorisation widens the companies’ reach in immune-mediated therapies by adding a multi-indication biosimilar to their portfolio.
• Gobivaz’s clinical and pharmacokinetic evidence base reinforces its positioning as a comparable treatment option across several immune-mediated conditions.

Alvotech and Advanz Pharma have secured European Commission marketing authorisations for Gobivaz, marking the first approval in the European Economic Area for a biosimilar referencing Simponi (golimumab).

The green light extends to Gobivaz 50 mg/0.5 mL and 100 mg/mL, which will be available in both pre-filled syringe formats equipped with a passive needle safety guard as well as autoinjector. The therapy is cleared for adult patients with rheumatoid arthritis when used with methotrexate, psoriatic arthritis either in combination with or without methotrexate, axial spondyloarthritis, ulcerative colitis, and for children aged two or older with juvenile idiopathic arthritis in combination with methotrexate.

Robert Wessman, Chairman and Chief Executive Officer of Alvotech, said: “This milestone marks the second biosimilar to receive approval through our partnership with Advanz Pharma and further strengthens the commercial presence we are building in Europe. As the first biosimilar to Simponi (golimumab) to gain approval in the European market, we are committed to expanding access to high quality biologic medicines for people living with immune-mediated diseases while providing value to healthcare systems throughout the region.”

Steffen Wagner, Chief Executive Officer of Advanz Pharma, added: “We welcome the EC approval of Gobivaz, an important milestone in our partnership with Alvotech. Expanding access to high-quality biosimilars is central to Advanz Pharma’s mission, and this approval enables us to offer patients across Europe a valuable new treatment option for immune-mediated diseases.”

The collaboration between Alvotech and Advanz outlines a clear division of responsibilities: Alvotech oversees development and commercial supply, while Advanz Pharma manages registration and has exclusive commercialisation rights for the EEA and the UK.

The EC decision rests on a totality of evidence, supported by clinical and pharmacokinetic studies that demonstrated the biosimilar’s comparability. With this authorisation now in place, the two companies are positioned to further scale their biosimilar footprint across Europe’s immune-mediated disease landscape.

The back-to-back approvals position Lynkuet as one of Bayer’s most strategically important pipeline assets, reflecting the commercial potential of a product aimed at a rapidly expanding patient base and a therapeutic category undergoing accelerated innovation. With decisions now finalised on both sides of the Atlantic, Bayer is preparing to scale the rollout across major pharmaceutical markets.

The European Commission has authorised Lynkuet menopause treatment (elinzanetant) for moderate to severe VMS linked to menopause or endocrine treatment for breast cancer. This follows the FDA’s approval, granted roughly one month earlier, for the menopause-related VMS indication in the U.S. The drug, an oral neurokinin (NK) 1 and 3 antagonist, enters a competitive field currently led by Astellas’ NK 3 antagonist Veozah/Veoza (fezolinetant), which received its first approval in 2023 for menopause-related VMS.

Market interest in non-hormonal VMS therapies has grown steadily, with Astellas reporting that Veozah/Veoza sales rose nearly 55% in the first six months of the current fiscal year to approximately $146 million. However, updated FDA labeling that includes a warning on rare but serious liver injury has reshaped expectations for the product’s long-term growth. Lynkuet menopause treatment faces related considerations, as its use has been linked to elevated liver enzyme levels requiring regular blood-test monitoring.

Bayer has positioned Lynkuet as its next major pharmaceutical launch, planning commercial availability in the U.S. this month. The therapy has now been approved in the U.S., EU, UK, Australia, Canada, and Switzerland. Demand potential is extensive: an estimated 1.2 billion women worldwide are expected to experience menopause by 2030, while millions receive breast cancer diagnoses each year, with about 70% presenting HR-positive tumours treated with endocrine therapies that commonly induce VMS.

“Menopause symptoms, including hot flashes, can greatly affect women’s quality of life,” said Nick Panay, a gynaecologist at Imperial College London and a principal investigator in one of the supporting clinical trials. “This approval is an important milestone in the area of menopause care as it expands therapeutic options for women experiencing distressing menopause symptoms with a novel targeted hormone-free treatment and facilitates healthcare professionals to achieve more personalised treatment,” he added.

A potential variable for the drug’s commercial trajectory is the FDA’s recent removal of black-box warnings related to breast cancer, cardiovascular disease, and dementia from hormone replacement therapies (HRT), a shift that could renew interest in hormonal treatments and influence uptake of newer non-hormonal options.

At the new manufacturing facility, Lilly will manufacture a variety of oral solid medicines spanning key therapeutic areas, including cardiometabolic health, neuroscience, oncology, and immunology. It will also include advanced production systems like dock-to-dock automation, paperless operations, and analytical technologies to enhance efficiency and uphold high manufacturing standards. The site will also use spray-dried dispersion technology to improve the absorption and effectiveness of oral medications. Among its first outputs will be orforglipron, Lilly’s initial oral, small-molecule GLP-1 receptor agonist, which the company intends to submit for global obesity regulatory review by year-end.

“With extensive investments already underway in the U.S., our planned expansion in Europe further strengthens our ability to deliver medicines to patients worldwide. Localized manufacturing ensures we can quickly respond to meet regional demand and accelerate distribution within Europe,” said David A. Ricks, Lilly chair and CEO. “Leiden Bio Science Park offers access to a skilled workforce, reliable infrastructure and proven pharmaceutical manufacturing capabilities. We look forward to working closely with the EU, national and local governments to create a more favorable and predictable policy environment open to fully harnessing innovative medicines to deliver faster access to patients.”

The development is expected to create 500 high-paying positions across engineering, science, operations, and laboratory functions, with an additional 1,500 construction jobs generated during the build phase beginning next year. The investment remains dependent on the completion of government permits and local approvals. “I’m truly proud that Lilly has chosen the Netherlands, Katwijk and the Leiden Bio Science Park after considering many locations across Europe,” said Vincent Karremans, minister of Economic Affairs of the Netherlands. “The arrival of Lilly will not only bring new jobs and investments but also boost collaboration in the field of innovative medicines, helping us work together on solutions that truly improve people’s health and lives.”

Lilly already operates manufacturing sites in France, Ireland, Italy, and Spain and has revealed plans for three additional European Union facilities since 2020 — in Ireland, Germany, and now the Netherlands. The Netherlands’ strong life sciences business climate, recently ranked among the top globally, aligns with Lilly’s continued investment in regional production. “At Lilly, we are investing in next-generation manufacturing facilities around the world to ensure our medicines are made and distributed closer to the communities and patients we serve,” said Edgardo Hernandez, executive vice president and president of Lilly Manufacturing Operations. “Expanding our capabilities in Europe strengthens our global supply chain and reflects our commitment to getting innovative treatments to patients who need them.” He added that each new facility is designed to achieve carbon neutrality and eliminate waste to landfills.

The company has also disclosed ongoing manufacturing expansion in Puerto Rico and new facility developments in Texas and Virginia, with announcements on two additional U.S. locations expected in the coming months.

NF1 is a rare genetic disorder that usually appears in early childhood and often carries on into adulthood, affecting several organ systems along the way. As many as half of people with the condition can develop PN, a non-cancerous tumour that forms in the brain, spinal cord, or peripheral nerves. Over time, these growths can enlarge and cause pain, disfigurement, or muscle weakness, along with other complications.

Prof. Pierre Wolkenstein, MD, PhD, Head of Dermatology at Henri Mondor Hospital, APHP, Paris East University (UPEC), and European National Coordinating Investigator of the KOMET trial, said: “The approval of Koselugo for adults with NF1 PN in Europe offers patients and physicians a meaningful approach to close treatment gaps beyond childhood. As demonstrated in the KOMET Phase III trial, the most robust late-stage clinical trial conducted in this patient group to-date, adults administered Koselugo saw significant tumour volume reduction with a safety profile consistent with its established use in paediatric patients, validating the clinical benefits of Koselugo for newly diagnosed adults and those transitioning to adult care.”

Marc Dunoyer, Chief Executive Officer at Alexion, commented: “The European Commission approval extends the life-changing potential of Koselugo to adults with NF1 PN in the region, including continuity of care into adulthood. This milestone, along with our pioneering leadership in NF1 PN treatment landscape, embodies Alexion’s unwavering commitment to addressing the unmet needs in the rare disease community. We look forward to bringing Koselugo to those adults in need across Europe as soon as possible.”

In the primary analysis of KOMET, Koselugo demonstrated a statistically significant objective response rate (ORR) of 20% (n=14/71, 95% CI: 11.2, 30.9) compared with 5% for placebo (n=4/74, 95% CI: 1.5, 13.3; p=0.01) by cycle 16. Following 12 cycles, patients receiving placebo were switched to Koselugo, while those already on Koselugo continued therapy for another 12 cycles. The drug’s safety profile in adults aligned with its established performance in paediatric use.

In addition to EU approval for Koselugo, the drug has also secured approval in Japan and several other markets for the treatment of adult NF1 patients with symptomatic, inoperable PN, based on data from the KOMET Phase III trial, with additional regulatory assessments currently underway.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) are offering early access to the aligned pathway six months ahead of schedule, as initial user research helps shape the programme’s next phase. Manufacturers whose medicines have received early access designation from NICE and the MHRA can now submit applications to the pathway.

Designed to support the government’s Regulatory Action Plan, the 10-Year Health Plan for England, and the Life Sciences Sector Plan, the aligned pathway integrates regulatory processes to speed up patient access and enhance the UK’s global competitiveness in life sciences. The pathway brings together the MHRA’s licensing process and NICE’s value assessment so that decisions come out at the same time, instead of one after the other. This cuts the 90-day gap between marketing authorisation and NICE guidance, giving patients quicker access, helping the NHS, and creating a smoother process for the industry.

A fully integrated joint scientific advice service will launch by April 2026, providing a single entry point for coordinated guidance from both organisations. It is designed to help companies prevent delays, get clarity on evidence requirements early, and keep to the pathway timelines. It also aims to give firms more confidence in their investment decisions.

Pharmaceutical companies are encouraged to register products on UK PharmaScan at least three years before they seek marketing authorisation and to engage early with both the MHRA and NICE. Both organisations remain committed to working closely together to improve efficiency, transparency, and timely access to innovative treatments.

The aligned pathway, which MHRA and NICE announced in July 2025 after the Regulatory Action Plan was published by HMT in March, asks companies to commit globally to its timelines. NICE will prioritise scheduling for medicinal topics on the pathway, so evaluations and regulatory decisions are published at the same time.

Titled ABPI Scotland: A Manifesto for Health and Growth, the document was released in advance of the upcoming Scottish Parliament elections. It calls on all parties to adopt policies aimed at improving patient outcomes, enhancing NHS delivery, and drawing internationally mobile investment in research, development, and advanced manufacturing. The pharmaceutical sector, the ABPI noted, underpins Scotland’s economy by supporting more than 15,000 high-value jobs and generating over £1.7 billion annually, achievements built on collaboration among the “triple helix” of government (the NHS), academia, and industry.

Despite the strengths of Scottish pharma sector, uptake of new medicines remains inconsistent, leaving patients facing what the ABPI described as postcode lotteries and delays. These challenges, it warned, risk deepening inequalities, forcing some to seek private care while others experience worsening health and financial strain. Richard Torbett, Chief Executive of the ABPI, stressed: “Better health and a stronger economy go hand in hand, and Scotland can have both. With the right policy choices, Scotland can become a powerhouse for the discovery, development and delivery of cutting-edge medicines, vaccines and diagnostics. He added: “The next Scottish Parliament offers a critical window to reset industrial and NHS innovation policy to attract investment and benefit patients, but global competition for that investment has never been higher. The opportunity from Scotland’s life sciences sector is real — but unlocking it depends on bold choices that put research, innovation and patient access at the heart of Scotland’s health and industrial strategy.”

The manifesto highlights the need to accelerate patient access to new medicines and vaccines, strengthen the Scottish pharma sector in research and innovation, and drive digital transformation through responsible use of health data. Currently, patients wait an average of 374 days for access to licensed medicines, while only 28% of treatments available to European patients are fully accessible in Scotland — compared with 90% in Germany and 37% in England. Torbett emphasized: “Every patient should be able to access Scottish Medicines Consortium (SMC) – approved treatments quickly, consistently and fairly. Spending on medicines must be recognised as an investment in health as well as NHS efficiency and financial sustainability. By investing in cutting-edge treatments and vaccines, we can drive disease prevention, improve treatable mortality, and generate economic growth for Scotland by reducing economic inactivity.”

To address these challenges, the ABPI set out three areas for government focus. 

First, to guarantee patient access to advanced treatments and vaccines: 

• Incentivising rapid adoption by Health Boards
• ensuring the Scottish Medicines Consortium is properly resourced
• requiring transparency through adoption reporting

Second, to establish Scotland as a hub for research and innovation: 

• Expanding “triple-helix” collaboration through initiatives such as the CATALYST programme
• Improving transparency in trial income reporting
• streamlining approvals with “Once for Scotland” approach.
• Reinforcing NHS–industry partnerships. 

Third, to advance the use of health data: 

• Implementing a national strategy led by the Health Secretary, 
• Investing in core infrastructure such as disease registries
• Building public trust through transparent governance and annual progress updates.

Argo focuses on creating innovative therapeutics that utilize RNA interference (RNAi) technology, a mechanism that silences genes that are involved in disease progression or renders them ineffective. The agreement extends to an RNA-based therapy BW-00112 expected to begin clinical evaluation in the coming year.

Argo further announced that Novartis has indicated a non-binding interest in joining its next equity financing round. In total, the collaborative framework is worth over $9 billion in downstream milestone opportunities, not including royalties, and serves to underscore the scope of the strategic alliance between Novartis and Argo Biopharma.

The drug BW-00112 is in mid-stage development as a new potential treatment for acute hypertriglyceridemia, which leads to a very high level of fat in the blood and increases the risk of cardiovascular risks such as heart attack and stroke. In the wider field of RNAi therapeutics, Alnylam’s vutrisiran, marketed as Amvuttra, has already received U.S. approval for treating transthyretin amyloid cardiomyopathy, a rare but serious heart disorder.

Argo’s candidates, which are designed to “deeply and durably target disease-causing proteins, represent an important paradigm shift in the prevention and treatment of cardiovascular diseases,” stated Shaun Coughlin, Global Head of Cardiovascular and Metabolism at Novartis Biomedical Research.

Under the terms of the Novartis and Argo deal, Argo will receive an upfront payment of $160 million, with the potential to earn up to $5.2 billion in milestone payments and royalties tied to future sales. Novartis will also gain options to license two discovery-stage drug candidates, one focused on severe hypertriglyceridemia and another targeting mixed dyslipidemia. Furthermore, the deal extends to an RNA therapy that is set to start clinical testing next year.

Argo also revealed that Novartis has shown a non-binding interest in joining its subsequent equity financing round. Collectively, the collaboration structure presents over $9 billion worth of downstream milestone potential, excluding royalties.

Earlier, US President Donald Trump had indicated that pharmaceuticals would not be covered by the preliminary framework agreed upon with the European Commission, a move that would have exposed European drugmakers to pharmaceutical tariff levels as high as 200% or even 250%. This move was in alignment with the president’s goal to increase domestic production of pharmaceuticals. “We want pharmaceuticals made in our country,” President Trump told CNBC.

Details released confirmed that pharmaceuticals will be included under the tariff structure, aligning with most other sectors and ensuring a ceiling of 15%. This development reduces the risk of disruptive cost pressures on companies that supply the US market.

Ireland, one of the EU’s leading pharmaceutical exporters, had been particularly vulnerable to the proposed higher tariffs. Welcoming the outcome, Ireland’s Deputy Prime Minister and Foreign Minister Simon Harris said, “This provides an important shield to Irish exporters that could have been subject to much larger tariffs,” 

EU Commission President Ursula von der Leyen stressed that the agreement adds predictability for businesses and consumers, describing it as a step toward greater stability in one of the world’s most significant trading partnerships.

The decision also safeguards the position of major European drugmakers with strong ties to the US market, including Denmark-based Novo Nordisk, the manufacturer of Ozempic. 

For the industry, 15% rate represents a crucial safeguard, ensuring that essential supply chains remain steady while broader negotiations between the EU and the US continue.