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Huiya Wu, JD, and Freddy Yip, PhD, PCLL, attorneys at Goodwin Procter, discussed biologic drug patent laws in China and the US.

US vs China: Goodwin Attorneys Discuss Patent Hurdles and Adalimumab Marketing 

Tony Hagen is senior managing editor for The Center for Biosimilars

Under the Biden administration, the Department of Justice (DOJ) has reversed course and now backs the constitutionality of the Affordable Care Act (ACA).

DOJ Withdraws Support for ACA Strikedown

Authors of a new study conclude that artificial intelligence could improve the selection of biosimilars for therapy. 

Study: Machine Learning Could Optimize Biosimilar Therapy

Incremental gains in the number of approved biosimilars and no new biologic categories were the low points, but uptake and improved patient access were highlights of 2020.

CfB Board Members Reflect on Year in Biosimilars

Stacie Ropka, JD, PhD, is a partner at Axinn. Her practice focuses on intellectual property litigation, due diligence, and client counseling, with an emphasis on the life sciences. Ropka’s experience includes extensive counseling for product development efforts relating to biologics and reconstructive biomaterials, including products that utilize adult stem cells. Prior to attending law school, she held a faculty position at SUNY Upstate Medical University, and she also spent many years as a research scientist in the fields of neurology, virology, and immunology.

Drew Hillier, JD, is an associate at Axinn. He litigates patent cases and high-stakes commercial disputes. His experience includes advising follow-on biologic manufacturers on product development and litigation strategy. As a former federal law clerk, Hillier has litigated patent-related cases in some of the highest-profile districts in the country, including the Southern District of New York and the Eastern District of Texas.

Gabriella Mahan, JD, is an associate at Axinn’s Washington, DC office. At the time of this writing, her admission to the Washington, DC Bar is pending.

Intellectual property law attorneys from Axinn discuss regulatory and legal events in 2020 that will affect biosimilar markets in 2021.

Opinion: The Legal and Regulatory Year in Review

In November, the Supreme Court heard arguments on the Affordable Care Act, Europe fired up its efforts to create a more biosimilar-friendly environment, and Genentech fought to protect its bevacizumab franchise.

Biosimilar Legal Roundup: November 2020

The European Commission (EC) said it will take the lessons learned from the coronavirus disease 2019 (COVID-19) pandemic and build a better marketplace for generics and biosimilars.

EC Eyes Enhancements for a Post–COVID-19 Marketplace

Meaghan Rose Smith's appointment comes during a time of challenges for the biologics industry.

Biosimilars Forum Chooses Director With Democratic Influence

Despite a rocky power transition at the federal level, the compass heading for biosimilars is unchanged, said policy expert Molly Burich.  

Burich: Saving Grace for Biosimilars in 2021 Will Be Bipartisan Support 

The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.

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