Stay up to date on the latest biosimilars developments with our biosimilars webinars. Biosimilars serve as “generic” versions of biologic drugs. They are large molecular drugs produced by or derived from living organisms. Once a biologic drug’s patent expires, biopharmaceutical companies design and market a similar molecule.

Despite much talk about their potential, biosimilars have not yet reduced healthcare costs or spurred the expected competition in the biopharma industry. Still, the FDA continues to approve new biosimilars across multiple drug classes — from insulins to arthritis drugs.

Although biosimilars closely resemble branded biologics, they are not molecularly identical, which distinguishes them from generic synthetic drugs.

Because of these differences, pharmacists cannot automatically substitute a biosimilar for its branded biologic. In 2021, however, the FDA approved Semglee—the first interchangeable biological product for Sanofi’s diabetes drug Lantus (insulin glargine). Mylan Pharmaceuticals developed Semglee, and clinical trials found no clinically meaningful difference compared to Lantus. Now, pharmacists can fill prescriptions for Lantus with Semglee when appropriate without consulting the prescribing physician.

There is a wide range of topics covered on our biosimilars webinars page from testing immunogenicity of biosimilar drugs and assessing the efficacy of biosimilars in clinical trials, to conducting safety assessments of biosimilars and meeting FDA guidelines.