August 12, 2020

Volume X, Number 225

August 12, 2020

Subscribe to Latest Legal News and Analysis

August 11, 2020

Subscribe to Latest Legal News and Analysis

August 10, 2020

Subscribe to Latest Legal News and Analysis

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new abbreviated FDA licensure pathway for highly similar biological products called biosimilars.  Yesterday, a three-judge panel of the Federal Circuit Court of Appeals issued a unanimous opinion interpreting the BPCIA’s provision that requires biosimilar applicants to give reference product sponsors Notice of Commercial Marketing at least 180 days before market launch of the biosimilar.  The question presented was whether compliance with the so-called Patent Dance provisions of the BPCIA obviates the need for a biosimilar applicant to provide that 180-day notice.  The court stated clearly that the answer to that question is “No” and that notice of commercial marketing is always required after FDA’s date of licensure for the biosimilar.  Our IP colleague Tom Wintner explains the importance of this Amgen Inc. v. Apotex Inc.

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume VI, Number 244

TRENDING LEGAL ANALYSIS


About this Author

Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to...

202.434.7349