FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further

When the Food and Drug Administration (FDA) approved the first biosimilar pegfilgrastim (Mylan’s Fulphila™), it broke precedent in more ways than one. Not only was this the first biosimilar member of the pegfilgrastim class to be approved, but its approval did not require an FDA Advisory Committee recommendation.

The FDA has been a bit fuzzy with respect to when an FDA Advisory Committee will be necessary. In the past, however, these AdComms had been required for all first biosimilar approvals to a new reference product. This was the case for filgrastim, infliximab, etanercept, trastuzumab, bevacizumab, adalimumab, and epoetin. Second biosimilars did not always require an AdComm, most recently last September with Boehringer Ingelheim’s Cyltezo®, the second adalimumab approved by FDA.

FDA Advisory CommitteeVarious problems with the 4 pegfilgrastim biologic license applications and resubmissions have provided the FDA ample time to review data and mull the consequences of approval or rejection. This case could be an exception. A greater challenge may be upcoming though.

Not that a great deal was achieved with the biosimilar AdComms. In general, votes for recommended approvals have been unanimous or lopsided. A recommendation for approval does not always result in approval—sticky manufacturing issues have gotten in the way (e.g., for Pfizer’s Retacrit). The FDA Advisory Committee meetings does give the public and other stakeholders a chance to air their views. Generally, this has been not for or against the biosimilar being reviewed but for or against biosimilars as a whole.

In March, I raised the case of Adello Biologics, which is attempting to gain approval of its filgrastim biosimilar without any phase 2 or phase 3 clinical data. This may be the second filgrastim biosimilar approved, so the FDA can avoid an AdComm on this basis. More importantly though, this agent could be the first biosimilar approved without any patient-based clinical testing (phase 1 is usually conducted in healthy volunteers). The next FDA Blood Products AdComm is not scheduled until November 29, 2018, and we do not know if Adello’s product will be part of that discussion. With a submission date of September 2017, one would expect a decision from FDA in the third quarter of this year.

In other biosimilar news… Celltrion resubmitted its 351(k) application to the FDA for its biosimilar version of trastuzumab. The original application resulted in an April 5 complete response letter for the Celltrion/Teva team.

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