Analysis Group Experts Publish Article Evaluating Potential Litigation Challenges for Biosimilars

September 22, 2016

This article was cited as one of Law360's 10 most-read expert analyses during the week of September 19, 2016

The potential widespread introduction of biosimilars in the United States represents one of the most impactful events to hit the drug industry in decades. The Biologics Price Competition and Innovation Act of 2009 paved the way for US biosimilar entry. Currently, three biosimilars have received FDA approval and more are expected soon. There are more than  50 biosimilars in the FDA Biosimilar Product Development Program, referencing over 15 different innovative biologics. The market entry of generic drugs initiated widespread litigation related to intellectual property disputes and alleged antitrust violations. In an article, “The Potential For Litigation In New Era Of Biosimilars,” published in Law360, Analysis Group Vice Presidents Christian Frois and Richard Mortimer, and Managing Principal Alan White explore whether biosimilars will face litigation of a similar nature and extent. The authors discuss how biosimilars differ from generic drugs in penetration rates, price discounts, scientific and manufacturing challenges, and branding, and examine how these variations could create broad potential for litigation related to patent disputes, product safety, and misleading promotion.

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