Biosimilar regulations and CMOs

Date: June 26, 2012  |  Time: 11 am ET / 8 am PT  |  Duration: 1 hour
Hosted by:
Mark Hollmer, Editor,

Biosimilar legislation passed in 2010 guaranteed 12 years of patent protection to biotechs from biosimilar competition. But passing the law was the easy part. As FDA hashes out regulations to implement the law, we help the industry to understand the significance of the legislation when it comes to outsourcing and how the new legislation may help, or hurt, contract manufacturing for biologics.


Michael A. Swit, Esq., Special Counsel, Duane Morris, LLP
Michael A. Swit, Esq., is a Special Counsel in the San Diego office of the international law firm, Duane Morris, LLP, where he focuses his practice on solving FDA legal challenges faced by highly-regulated pharmaceutical and medical device companies. Before joining Duane Morris in March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences.

Linda D. Bentley, Member, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Linda advises health products manufacturers on the regulatory and reimbursement status of products and procedures and on strategic pathways for bringing new products to market. She counsels clients on compliance with the Federal Food, Drug, and Cosmetic Act and related matters, such as arrangements for outsourced services, labeling and advertising, and requests for orphan drug and fast track designations. She also provides advice on the regulatory issues relating to in vitro diagnostic products, including laboratory developed tests and companion diagnostics.

Kelly Davis, Regulatory Affairs Associate Director, Baxter BioPharma Solutions
Ms. Davis has over 18 years of pharmaceutical experience in regulatory affairs, quality assurance and quality control. In her current role, she is responsible for providing global strategic business direction based upon current industry trends, regulatory agency guidance and regulations, and market need. In addition, Ms. Davis leads a team that is responsible for writing global CMC application sections, maintaining global licenses, and evaluating product and facility improvement initiatives for global license impact.