Drugmakers Split on Cruciality of Certain Clinical Tests for Showing Biosimilarity

Drugmakers commenting on the FDA’s trio of biosimilars guidance documents are split on the need for certain clinical tests as part of the agency’s stepwise approach to showing biosimilarity. The comments, which were due to the agency Monday, find drugmakers generally impressed with the FDA’s efforts to implement the statutory approval pathway for biosimilars. However, they say more precise language is needed to clarify a host of key issues.
Drug Industry Daily