Global Biosimilar Update

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The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe.  As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or rectal carcinoma, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical carcinoma.

Prestige BioPharma and Pharmapark have entered into a partnership and supply agreement to commercialize Prestige’s bevacizumab biosimilar, HD204, in the Russian Federation.   Prestige BioPharma will be responsible for commercial supply of HD204, using its manufacturing facilities in Korea, and Pharmapark will be responsible for local registration, sales, and marketing of HD204 in the Russian Federation.  This partnership and supply agreement builds on the 2019 licensing agreement between the two companies, which involved Prestige BioPharma’s Herceptin biosimilar.

In British Columbia, patients taking Humira have begun transitioning to one of five adalimumab biosimilars:  Amgevita, Hadlima, Hulio, Hyrimoz, and Idacio.  The process is expected to affect almost 6,000 patients, and to occur over a six-month period.   Adrian Dix, Minister of Health, explained that “As thousands more patients transition to the next biosimilar (adalimumab), B.C. will save over $100 million over three years. This is in addition to savings from earlier phases of the program that are being reinvested in our health-care system. These savings have allowed us to expand coverage of treatments and add more drugs to our formulary to offer more affordable medications for British Columbians.”

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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