Business of Biosimilars Day 1: Biosimilar R&D Planning and Protecting IP

Today's guest post features highlights from the first day of the Business of Biosimilars and Generic Drugs Summit and is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.

The presenters for the Summit portion of the 13th Annual Business of Biosimilars and Generic Drugs meeting discussed the biotherapeutic research and development, and legal criteria surrounding biosimilar development. The day began with a presentation from Michael Malecki, Senior Manager, Biosimilars, Amgen who discussed the importance of long term follow up of biosimilar therapies. He stressed the importance of placing value in due diligence and putting patient safety above all. This was further highlighted by the World Health Organizations Global Harmonization Guidelines, which stated that biosimilar manufacturers should look for differences that could ultimately be clinically meaningful.

The presentation by Magdalena Leszczyniecka, CEO, STC Biologics focused on potential variability during biosimilar development and the importance of robust analytics in mitigating potentially harmful effects to patients. She also stressed that during biosimilar development manufacturers must focus more on quality than high titers. Also, modifications to the biosimilar can occur during cell culture and/or purification suggesting that both upstream and downstream processes impact overall safety and efficacy.

The presentation by Michael Bauer, IP Counsel, Hospira stressed that the size and complexity of biosimilars offers increased patentability for parties developing biotherapeutics. He also stressed that biosimilar manufacturers must be aware of entire the process of biosimilar litigation and begin long before filing to assemble a legal team, to include additional backup counsel, to properly defend its biosimilar interests. In addition, Mark Hyman, IP Counsel, Human Genome Sciences gave a detailed description of the legal aspects of IP litigation with respect to biosimilar manufacturers in litigation with innovator companies. The final presenter was Michael Castagna, Executive Director of Immunoscience, Bristol Myers Squibb who stressed gave an assessment of the key areas that biosimilar manufacturers need to be aware of when deciding to develop biosimilars.

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