If you’re looking to stay up to date on the latest in the biosimilars drug space, then our collection of biosimilars webinars is right for you. Biosimilars are so-called “generic” forms of biologic drugs. Like originator biologics, they are generally larger molecular drugs derived from, or made by, an organism. Once the patent for the original biologic drug has expired, biopharmaceutical companies can design a similar molecule to be marketed.
Though there has been much talk about the promise of biosimilars in recent years, they largely haven’t lived up to the hype in terms of reducing healthcare costs and introducing some much-needed competition in the biopharma industry. Still, the FDA has continued to approve new biosimilars in multiple drug classes – from insulins to arthritis drugs.
While biosimilars are considered to be “highly similar” to their branded biologic counterparts, they are not molecularly identical. This is what sets them apart from generic versions of synthetic pharmaceutical drugs.
For this reason, pharmacists are not permitted to fill a patient’s prescription for a biologic drug with its potentially less-expensive biosimilar version. However, in 2021, the FDA approved the first interchangeable biological product for Sanofi’s diabetes drug Lantus (insulin glargine), a biosimilar named Semglee (long-acting insulin glargine) which was developed by Mylan Pharmaceuticals. Because Semglee showed no clinically meaningful difference compared to its reference product Lantus in trials, it was granted this coveted status. Pharmacists will now be able to fill prescriptions for Lantus with Semglee if they think it’s appropriate without having to consult 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.