Report: Payers may require more clinical data on follow-on biologics

08/9/2011 | PharmaTimes (U.K.)

FDA approval might not be enough for insurers to cover generic copies of biotech drugs, according to a report from Decision Resources. "Because [monoclonal antibodies] are highly complex biologics compared with more simple proteins, FDA approval will only go part way in satisfying payers' doubts over these more elaborate agents," said Andrew Merron, biosimilars advisory service director at Decision Resources. The FDA is still working on a definition for "similar" in the context of biologic drugs and is unlikely to promulgate a one-size-fits-all rule, agency officials said.

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