What’s the Future of Biosimilar Drugs Development?

In general, biosimilars are generic products of biopharmaceuticals. Different from generics, they are “similar” and therefore require approval procedures similar to new branded drugs.   Although there are about 25 approved biosimilars in Europe, they did not receive the same treatment in the United States. Despite 11 drugs are approved in the United States, only about 3 kinds can be utilized in patients for branded pharmaceutical companies are using commercial…

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Learn FDA’s Review of Bio-similar from ABP215

biosimilars

ABP215 is a biosimilar drug developed by Amgen and Allergan, using Avastin (bevacizumab) as a prototype drug. Amgen filed a drug application to the FDA in November 2016. The FDA Oncologic Drugs Advisory Committee (ODAC) met on July 13, 2017, and the members voted in favor of approving the ABP215 drug application. The ABP215 is expected to become America’s first Avastin bio-similar drug. Liu Shining, the research manager in TrendForce,…

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