Biosimilars

Biologic medications are those that generally derive from an organism, often manufactured using recombinant DNA technology. For example, insulin is a biologic and many peptide medications are biologics. Biosimilars are a type of biologic that is highly similar to another biologic that is already FDA-approved.¹

In December 2019, the FDA released “Statement on low-cost biosimilar and interchangeable protein products”, which created an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market. This removed an exclusion of chemically synthesized polypeptides. “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.”²

The FDA has some good resources on Biosimilars here:

https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices

FDA Guidance for Industry:

ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry

Resources:

1. Office of the Commissioner. Biosimilar and Interchangeable Biologics: More treatment choices. US Food And Drug Administration. August 2023. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices.
2. Office of the Commissioner. Statement on low-cost biosimilar and interchangeable protein products. US Food And Drug Administration. December 2019. https://www.fda.gov/news-events/press-announcements/statement-low-cost-biosimilar-and-interchangeable-protein-products.