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Skadden publishes article on biosimilars transactions
Skadden said it published an article on how FDA regulatory reform, the maturing biosimilar patent framework and coming patent expirations are reshaping biosimilars M&A. The firm said FDA draft guidance since October 2025 lets sponsors replace comparative efficacy studies with analytical and pharmacokinetic data, that 118 biologics are expected to lose protection between 2025 and 2034, and that licensing remains the most common deal structure alongside acquisitions.
Key points
- Skadden’s article discussed FDA regulatory reform.Skadden, Arps, Slate, Meagher & Flom
- The publication examined the patent-dispute framework for biosimilars.Skadden, Arps, Slate, Meagher & Flom
- Skadden addressed patent expirations and freedom-to-operate analysis.Skadden, Arps, Slate, Meagher & Flom
- The article compared licensing structures with acquisition strategies.Skadden, Arps, Slate, Meagher & Flom