Big Molecule Watch
September 28, 2023

Recent Biosimilar Commercialization Developments

Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., Ltd. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the U.S. market.  Meitheal and Tonghua Dongbao will be jointly responsible for development and supply, with the expectation of achieving FDA approval in 2026.

Oncology, Women’s Health, and Respiratory Disease Biosimilars: Abbott has announced an expansion of its agreement with mAbxience Holdings S.L. to commercialize several of Abbott’s oncology, women’s health, and respiratory disease biosimilars for emerging markets in Latin America, Southeast Asia, the Middle East, and Africa.  mAbxience, a Fresenius-Kabi majority-owned group, will be responsible for manufacturing and achieving clinical milestones.  According to the press release, the first molecules subject to the agreement are expected to launch as early as 2025.

Anti-Tumor Biosimilars: Chime Biologics Ltd., based in China, has entered into a strategic cooperation agreement as an exclusive provider of CDMO (contract development and manufacturing organization) services to Kings Pharm Corp., located in Korea, to commercialize Kings Pharm’s anti-tumor biosimilar for the global market.  Chime Biologics will be responsible for providing cell line development, early process development, global clinical and commercial manufacturing, and registration.

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