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US FDA approves biosimilar version of Lilly's osteoporosis drug Forteo

Pfenex Inc. said the U.S. Food and Drug Administration approved its application for PF708, a biosimilar of Eli Lilly and Co.'s osteoporosis drug Forteo.

PF708, like Forteo, can now be used to treat osteoporosis in certain patients at high risk of fracture.

Additionally, the San Diego-based company is requesting that the FDA assign PF708 as a therapeutically equivalent product to Forteo, which generated $360.8 million in second-quarter sales for Eli Lilly. The designation would allow PF708 to be automatically substituted for the Eli Lilly medicine in many states.

Pfenex is conducting a comparative human factors study between PF708 and Forteo to back the designation and as requested by the FDA. The final study report will be submitted to the U.S. regulator as early as the second half of October, Pfenex noted.

PF708 is under regulatory review by the European Medicines Agency. If approved in Europe, PF708 will be commercialized in Europe by private pharmaceutical company Theramex, subject to regulatory approvals.