Originator Biologics vs. Biosimilars | BioEngage from Amgen Biosimilars

Biosimilars Versus Reference Biologics

More than 30 years ago, the advent of biologic medicines forever changed the way we treat serious illnesses, including inflammatory diseases and cancers.1

Biologics are produced in genetically engineered living cells. They include therapeutic proteins, which replace or augment beneficial human proteins, and monoclonal antibodies, which can strike disease targets with enhanced precision.1,2

Biosimilars are biologic medicines that are highly similar to existing licensed biologic products with no clinically meaningful differences in terms of safety and efficacy.3

References: 1. Biosimilars Resource Center. What are biologics? www.biosimilarsresourcecenter.org/faq/what-are-biologics/. Accessed October 29, 2019. 2. Sathish JG, Sethu S, Bielsky MC, et al. Challenges and approaches for the development of safer immunomodulatory biologics. Nat Rev Drug Discov. 2013;12:206-324. 3. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda/gov/downloads/drugs/guidances.ucm291128.pdf. Accessed October 29, 2019.