Formycon and Biocon Biologics/Viatris Share Recent Biosimilars Development News

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On March 1, 2021, Formycon announced that it plans to resubmit its BLA for its Lucentis® Biosimilar Candidate FBY201 (ranibizumab) in the first half of 2021.  Formycon expects to submit its application to the EMA soon thereafter, and will also seek approval in Canada, Australia, the United Kingdom and Switzerland.

Also on March 1, 2021, Biocon Biologics, Ltd. announced that the EMA CHMP has recommended approval of Biocon’s biosimilar bevacizumab, which will be marketed as Abevmy.  Biocon co-developed its product with Viatris.  Biocon expects final approval of its product in May 2021.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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