September 24, 2023
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Amgen agrees to develop biosimilars for Chinese market


Increasing its global footprint in the biosimilars market, Amgen announced Sept. 26 that it had formed an exclusive co-development agreement with Chinese drug manufacturer Simcere Pharmaceutical Group.

The agreement aims to bring four oncology and inflammation biosimilars in Amgen’s portfolio to commercialization in China. The Thousand Oaks-based biotechnology company will produce and submit approval applications for the drugs, while Simcere will handle Chinese distribution and commercialization.

“This agreement brings together Amgen’s long-standing development and biologics manufacturing expertise with Simcere’s local development experience and strong commercial presence in China in the areas of inflammation and oncology,” Scott Foraker, Amgen’s vice president and general manager of biosimilars, said in a news release.

The move comes after recent reforms to the China Food and Drug Administration’s evaluation and approval systems, said Hua Mu, chief scientific officer at Simcere.

“This strategic alliance combines Amgen’s leading global research and development capabilities in biosimilars and Simcere’s domestic drug development and registration experience,” he said. “It aims to bring more high quality and effective medicines to Chinese patients to meet the pressing unmet medical needs. It is also another important milestone in our international collaboration strategy to enrich Simcere’s biologics pipeline.”

Financial terms of the deal were not disclosed.

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