Recent Launches - Formycon, bioeq and Boryung, Samsung Bioepis

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On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration.  FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases.  If approved, Coherus Biosciences, Inc. will commercialize FYB201 (also known as CHS-201) in the United States according to the terms of a November 2019 license and development agreement between Coherus and Bioeq.  Bioeq also submitted marketing authorization applications for FYB201 to the European Medicines Agency in June 2021 and to the UK MHRA in July 2021.  Bioeq expects to introduce its FYB201 biosimilar to the U.S. and European markets in 2022.  The commercialization of FYB201 in Europe, Canada, Israel and New Zealand will be performed by Teva Pharmaceutical Industries Ltd., which acquired distribution rights under an exclusive strategic partnership from Bioeq.

The Korea Biomedical Review reported that on September 1, 2021, Boryung Pharmaceutical announced its launch of Onbevzi, a biosimilar for Avastin (Bevacizumab) developed by Samsung Bioepis in Korea.  Boryung acquired exclusive sales rights for Onbevzi from Samsung in May of this year and, according to the company, it will become the first Avastin biosimilar available in Korea.  The company is quoted as saying that Onbevzi “has proven its efficacy and safety on par with Avastin, the original product, through phase 1 and 3 clinical trials,” but “is 37 percent cheaper than Avastin’s insured-price enabling more patients to receive treatment opportunities and has a longer shelf life of 36 months compared to the 24 months for Avastin.”

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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