ARTICLE
18 February 2022

International Biosimilar Approval And Launch Updates

GP
Goodwin Procter LLP

Contributor

At Goodwin, we partner with our clients to practice law with integrity, ingenuity, agility, and ambition. Our 1,600 lawyers across the United States, Europe, and Asia excel at complex transactions, high-stakes litigation and world-class advisory services in the technology, life sciences, real estate, private equity, and financial industries. Our unique combination of deep experience serving both the innovators and investors in a rapidly changing, technology-driven economy sets us apart.
Earlier this month, Samsung Bioepis Co. Ltd. announced that Health Canada approved ONTRUZANT (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer...
United States Food, Drugs, Healthcare, Life Sciences

Earlier this month, Samsung Bioepis Co. Ltd. announced that Health Canada approved ONTRUZANT (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer, Metastatic Breast Cancer and metastatic gastric cancer. ONTRUZANT is Samsung Bioepis' fifth biosimilar approved for the use in Canada following BRENZYS (etanercept) in August 2016, RENFLEXIS (infliximab) in December 2017, HADLIMA (adalimumab) in May 2018, AYBINTIO (bevacizumab) in November 2021.

Last week, Selexis SA and Generium JSC announced that GENOLAR, Generium's biosimilar of omalizumab, is now commercially available in Russia for the treatment of persistent atopic bronchial asthma and resistant chronic idiopathic urticaria. According to the press release, GENOLAR is the third Selexis biosimilar to reach the market under commercial license agreements between Generium and Selexis.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

See More Popular Content From

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More