The Biologics Price Competition and Innovation Act (BPCIA) created an abbreviated approval pathway for certain copycat versions of biological products, known as “biosimilars” and “interchangeable biological products.” Since BPCIA's enactment in 2010, FDA has developed numerous policies regarding how these products will be regulated and approved, including on the scientific considerations for approval, labeling and labeling carve-outs, nonproprietary naming, reference product (RP) exclusivity, transitional biologics, and interchangeability standards. In the last few years, the Agency also has approved several biosimilar products (with many more in the pipeline) but no interchangeable biologics. As the industry matures, more regulatory change is inevitable, and FDA's policies will continue to evolve, particularly on emerging issues such as interchangeability, RP exclusivity, and labeling carve-outs.

Biosimilars Expertise

Scott Lassman has been working on the complex legal and regulatory issues affecting biosimilars since the beginning. He has provided input, advocacy and counsel to a wide range of clients, including companies, associations and investors, on nearly every policy issue that has arisen since passage of BPCIA, including transitional biologics (e.g., insulin), biosimilar labeling, naming and RP exclusivity. Scott’s experience spans issues as diverse as FDA’s reliance on foreign reference standards to make biosimilarity determinations to whether FDA should apply an “umbrella policy” to RP exclusivity.

In addition to helping shape client advocacy on policy issues, Scott assists companies seeking approval of abbreviated Biologics License Applications (aBLA) for biosimilars and interchangeable biological products. This includes advice on a wide variety of legal, regulatory and even scientific issues, including labeling and labeling carve-outs, FDA approval standards, dispute resolution, and preparation for meetings with FDA and FDA Advisory Committees.

You are invited to contact Lassman Law+Policy for more information on the firm's counsel and advocacy with regard to biosimilars.