EMA releases draft guidelines for biosimilar mAbs

The European Medicines Agency released draft guidelines for the development of biosimilar mAbs that would require clinical non-inferiority trials when pharmacodynamics studies cannot "convincingly" show comparability to the reference mAb in a "clinically relevant manner." The draft noted that efficacy endpoints may differ from those recommended in existing CHMP guidelines if the endpoints are scientifically justified to establish biosimilarity. When a different endpoint is used, EMA said the endpoints usually recommended should be included as secondary endpoints where feasible.

For cancer indications, EMA recommended overall response rate as a primary endpoint. The agency said the preferred endpoints of progression-free survival (PFS) or overall survival (OS) may not be feasible or sensitive enough to establish biosimilarity since they may be influenced by factors such as tumor burden, previous lines of treatment or underlying clinical conditions. The guidance does recommend that PFS and OS should be recorded where feasible. EMA said the guidance may be relevant for related products, including fusion proteins based on the Fc portion of IgG. ...