From The Stage

Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation

Krystal J. Alligood
Posted by Krystal J. Alligood / / Biosimilars, Industry Update, Pharmacokinetics

According to research from the Biosimilars Council, $81 billion worth of brand name biologics will lose their patents by 2020. As a result, we are seeing a significant increase in the development of lower cost biosimilar alternatives, as well as more applications for FDA approval of biosimilars for expiring biologic drugs. In fact, this market is expected to grow more than 25-fold over the next five years. But because the structure of a biosimilar is unlikely to be identical to that of the reference product, developers must ensure there are…

Not the Same, But Not Too Different: Demonstrating ‘Biosimilarity’ for Biosimilars with Comparative PK and Immunogenicity Assays

Todd Lester
Posted by Todd Lester / / BioAgilytix Insight, Biosimilars

As per the Food and Drug Administration (FDA) guidance Quality Considerations in Demonstrating Biosimilarity to a Reference Product, a biosimilar is defined as “a biological product that is highly similar to a reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” Clinical pharmacology studies are a critical part of demonstrating this ‘biosimilarity’, and provide the data for the biosimilarity in drug…