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Biocon Biologics has become one of the most prominent global biosimilars firms since its buyout of former partner Viatris’ biosimilars business. With a rumored IPO instead making way for a merger with generics unit Biocon Ltd, the business’s chief Shreehas Tambe sets out the reasons for the move.
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.
Generics Bulletin reviews global regulatory developments across the world.
Amarin has hit back over the US Supreme Court’s decision to review skinny-label induced infringement litigation with Hikma over Vascepa (icosapent ethyl).
Speaking at a pre-J.P Morgan science summit, Sarah Yim – director of the US FDA’s Office of Therapeutic Biologics and Biosimilars – set out the FDA’s plans to achieve further progress on biosimilars both domestically and internationally in 2026.
Cosette Pharmaceuticals and Alembic Pharmaceuticals are among the latest firms to have benefited from 180 days of competitive generic therapy exclusivity under the US FDA’s CGT pathway. Since the first approval in 2018, almost 500 ANDAs referencing CGT products have been approved.
The health technology assessment institute said its recommendation for the multiple sclerosis drugs, Tysabri and Tyruko, highlighted its continued efforts to drive the adoption of biosimilars across the National Health Service.
The European Commission sees the value of biosimilars, but its biotech vision lacks competitive incentives to build on the region’s relevance.
Generics Bulletin reviews the first year of Trump 2.0 and its impact on the off-patent sector, which was marked by both favorable and less beneficial movements by US president Donald Trump and his administration.
Hyloris and Orion continue to build on their partnership with another value-added medicine collaboration in Europe.
European CNS specialist rolls out a value-added methylphenidate and a first-to-market guanfacine generic as it sharpens its European ADHD strategy.
Management says it is prepared to sacrifice early volume if pricing fails to reflect the drug’s role in moderate to severe schizophrenia.
Viatris is entering the new year with several key achievements under its belt.
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.
Amarin has hit back over the US Supreme Court’s decision to review skinny-label induced infringement litigation with Hikma over Vascepa (icosapent ethyl).
Marking the latest step in the long-running saga of Hikma and Amarin’s induced infringement dispute over Vascepa (icosapent ethyl), the US Supreme Court has agreed to review the litigation, which cuts to the heart of key issues around skinny-label generics and carved-out indications.
Unified Patent Court ruling removes legal overhang on cabazitaxel generics already on the European market.
