Biologic and Biosimilar Approval Updates

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.