The European Medicines Agency (EMA) is proposing to waive comparative efficacy studies (CES) for biosimilars with a straightforward mechanism of action (MOA), such as monoclonal antibodies and recombinant proteins, to reduce the need for human studies in comparing a biosimilar medicine under development with the reference product.
EMA published this proposal in a new concept paper published on 25 January, explaining that “when the biosimilar demonstrates a high degree of similarity to the RMP [Reference Medicinal Product] at the analytical and functional level, it may be possible to justify the omission of dedicated CES [clinical efficacy studies].”…
