Boehringer Ingelheim GmbH (Ingelheim, Germany) said it will focus its biosimilar development and partnering activities on the U.S. market and discontinue its biosimilar programs in the rest of the world.
Spokesperson Susan Holz told BioCentury that Boehringer’s first U.S. priority is to launch Cyltezo, a biosmilar version of autoimmune drug Humira adalimumab from AbbVie Inc. (NYSE:ABBV). FDA and the European Commission both approved Cyltezo last year. She said the company has dropped its plans to commercialize the biosimilar in the EU due to patent litigation with AbbVie in the U.S. Holz did not elaborate on the reasons for the company’s shift in plans, but said the company “is committed to making [Cyltezo] available to U.S. patients as soon as possible and certainly before 2023.” She declined to provide details on other biosimilars in its U.S. pipeline.
Last year, Amgen Inc. (NASDAQ:AMGN) agreed to pay AbbVie undisclosed royalties in exchange for rights to launch its Humira biosimilar in the EU on Oct. 16, 2018 and in the U.S. on Jan. 31, 2023. Amgen’s settlement came one month after AbbVie filed a federal lawsuit seeking to block Boehringer from launching Cyltezo (see “Amgen, AbbVie Settle Humira Biosimilar Dispute”.)
In April, Samsung Bioepis Co. Ltd. reached a similar settlement with AbbVie. Samsung Bioepis is a JV between Biogen Inc. (NASDAQ:BIIB) and Samsung BioLogics Co. Ltd.(KOSDAQ:207940) (see “Samsung Bioepis, AbbVie Settle Biosimilar Dispute”).
The company’s manufacturing facilities in China, Germany, Austria and the U.S. will continue to produce Boehringer’s marketed products and process development of new biological entities and biosimilars, Holz said. Boehringer is also a contract manufacturer for other pharmaceutical companies. Its biologics production includes mAbs for immunology and oncology, interferons and other targeted medicines.
Within the past two months, at least two other companies decided to discontinue development of biosimilars programs.
In November, Novartis AG (NYSE:NVS; SIX:NOVN) unit Sandoz said it will no longer seek U.S. approval of GP2013, its biosimilar of cancer and autoimmune drug Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY), due to two competing biosimilars under FDA review (see “Sandoz Gives Up on Rituxan Biosimilar in U.S.”).
In October, Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said it plans to terminate five biosimilar development programs under its 2016 co-development deal with Mylan N.V. (NASDAQ:MYL) and reduce headcount by about 50% to focus on its novel pipeline (see “Momenta Cutting Biosimilar Programs, Headcount”).
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