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Biosimilars
Generics Bulletin previews the most noteworthy and anticipated events for February 2026.
‘It’s A Great Opportunity But It’s Also Late’ – Samsung Bioepis’ Woollett On Biosimilar Streamlining
Regulatory streamlining represents a paradigm shift for the biosimilars industry, but does it go far enough? Gillian Woollett, Samsung Bioepis’ head of regulatory strategy and policy, says streamlining must be accompanied by a sustainable economic environment for biosimilars to ensure global access.
Alvotech has ticked off all of the remaining patent-related matters for its aflibercept biosimilar, with multiple market entries expected in 2026.
Teva says it has 10 additional biosimilars in development for launch from 2028 onwards, extending its portfolio beyond 2027 as it targets European growth and expands through partnerships.
Even though the ink has long dried on the US-South Korea trade deal, new threats have prompted Celltrion to reiterate its “fundamental solution” to tariff concerns.
With the separation from its parent company now behind it, Samsung Bioepis celebrated its highest-ever annual revenues and outlined its vision of further growth.
MS Pharma is continuing to capitalize on opportunities for localized manufacturing in the Middle East, with its latest deal with Hetero Biopharma covering five biosimilars.
Conclusion of India-EU talks sets ground for a free trade agreement to cut pharma tariffs, in turn lowering the cost for novel drugs like Novo’s obesity treatment Wegovy, though an investment protection agreement – likely influencing data exclusivity – will be concluded later.
Responding to recent FDA guidance on a new streamlined pathway for US biosimilars, off-patent industry representatives have urged the agency to make the approach “the new default” for biosimilar filings. However, PhRMA has suggested limiting the route to less complex product types.
As Dr Reddy’s delivered results for its financial third quarter, the firm revealed a slew of updates for key biosimilars in its pipeline including filing and launch plans for abatacept in the US and Europe, as well as US setbacks on rituximab and denosumab.
BMS will continue to seek legal recourse even as Zydus Lifesciences launches the world’s first cut-price nivolumab biosimilar in India following a Delhi High Court division bench ruling in favor of the Indian company.
Generics Bulletin reviews global regulatory developments across the world.