Translations:Biosimilar/11/en

In March 2020, most protein products that were approved as drug products (including every insulin currently on the market December 2019年現在) are scheduled to open up to biosimilar and interchangeable competition in the United States. However, "chemically synthesized polypeptides" are excluded from this transition, which means that a product that falls within this category won't be able to come to market as a biosimilar or interchangeable product, but will have to come to the market under a different pathway.