Biosimilars Update: Amsparity Authorized by EMA but EU Launch Not Expected

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On Feb. 13, 2020, the European Medicines Agency (EMA) granted market authorization for Amsparity, Pfizer’s adalimumab biosimilar.  Amsparity is approved for use in treating the same set of conditions as Humira in Europe. In 2018, Pfizer announced that it had reached a license agreement with AbbVie that allowed Pfizer to launch its adalimumab biosimilar in Europe upon approval by the EMA.  Despite receiving market authorization, Pfizer previously reported in its latest earnings report that it does not plan to launch Amsparity in Europe due to unfavorable market conditions.

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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