Linda Bentley will present at a FierceBiotech webinar entitled, "Biosimilar regulations and CMOs." 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.
Biosimilar legislation passed in 2010 guarantees 12 years of patent protection to biotechs from biosimilar competition. But passing the law was the easy part, as the FDA hashes out regulations to implement the law, CMOs need to understand the significance of the legislation to their businesses.
This webinar will outline the impact this legislation will have on businesses and how the new legislation may help or hurt contract manufacturing for biologics.
Mark Hollmer, Editor, FierceBiotechResearch
Linda D. Bentley, Member, Mintz Levin
Michael A. Swit, Special Counsel, Duane Morris, LLP
Kelly Davis, Regulatory Affairs Associate Director, Baxter BioPharma Solutions
Biosimilar regulations and CMOs