Biologic and Biosimilar Approval Updates

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The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy.  Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection.

Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab product, the first adalimumab biosimilar to Abbvie’s Humira® approved in Japan.  Commercialization of the product will be handled by Fujifilm’s partner, Mylan.

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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