Pfenex (NYSEMKT:PFNX) announces that
the FDA informed commercialization partner Alvogen Malta Operations
Ltd. that it needs additional comparative use human factors data
regarding PKF708, its biosimilar candidate to Eli Lilly’s (NYSE:LLY) osteoporosis med Forteo (teriparatide injection), before it can determine therapeutic equivalence.
CEO Eef Schimmelpennink is confident that they can generate the necessary data to meet the agency’s requirements.
The FDA approved PF708 in October 2019 under its abbreviated 505(b)(2) pathway with the proviso that it conduct a human factors study.
https://seekingalpha.com/news/3560762-pfenex-not-quite-full-u-s-approval-of-forteo-biosimilar
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.