Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients.

In March 2020 most protein products that were approved as drug products (including every insulin currently on the market) will open up to biosimilar and interchangeable competition. 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. Such a product would also not be able to come to market through the generic drug pathway because the originator product will have been classified as a biologic, and will not be available for copying. This exclusion could hurt potential competition because it means that if a developer were to chemically synthesize a copy of a protein product (e.g., an insulin copy), the product would not be able to come to market through the abbreviated biosimilar or interchangeable pathway, but instead would have to submit a new drug application, which could be much more resource-intensive.

Removing this exclusion will help patients because it provides the potential for chemically synthesized follow-on insulins and other protein products to come to market through more efficient abbreviated pathways, regardless of how they are manufactured. In addition to expanding access to lower-cost biosimilar and interchangeable protein products, removing this exclusion will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes.