12.03.20 -- 3 Perspectives On Biosimilars & Biobetter Development

In part two of this two-part article series, three experts share additional insights around the types of differentiation biosimilar companies can pursue and how differentiating impacts product/device selection and the manufacturing process. 

In this Q&A, Carol Lynch, president, U.S., and head, North America, for Sandoz, discusses the supply challenges she’s observed in the biologics space throughout the pandemic and the efforts biosimilar makers should be taking to meet patients’ needs and prepare for future supply disruptions.

Can a patent claim millions of different antibodies based on their function alone? Tens of thousands? Hundreds? What if the patent gives a plug and play roadmap to make and evaluate the antibodies through routine testing? Whatever the U.S. Court of Appeals for the Federal Circuit (CAFC) answers, one thing is certain: It will affect how biologics innovators use functional claiming and whether patentees or challengers are more likely to win future lawsuits in the biologics and biosimilar arena.