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Tony Hagen is senior managing editor for The Center for Biosimilars

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.

Genentech Files to Block Marketing of Centus' Bevacizumab Biosimilar

The court must decide whether Congress’ setting the shared responsibility payment to $0 means that the entire Affordable Care Act (ACA) statute is now unconstitutional. 

Biosimilars Poll: Which Way Will the Supreme Court Rule on the ACA?

Chad Landmon is a partner at Axinn, Veltrop & Harkrider LLP, where he chairs the firm’s Intellectual Property and FDA Practice Groups. He focuses his practice on patent litigation and counseling and food and drug law, with an emphasis on pharmaceuticals, biologics, medical devices, regenerative medicine, and human tissue products.

Jonathan Knowles, JD, is an associate at Axinn. At this time, his admission to the New York bar is pending.

Intellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).

Legal Opinion: BPCIA Is Likely to Survive Latest ACA Challenge

The survival of the biosimilars approval pathway seemed on surer footing today following oral arguments at the Supreme Court over the Affordable Care Act and the severability of its provisions.

Supreme Court Hints Biosimilar Route Might Be Preserved

Medicines for Europe, a generic and biosimilar trade association, contends in a white paper that legal and regulatory loopholes increasingly keep competing drugs off the market. 

Medicines for Europe Takes Aim at Barriers to Entry for Biosimilars and Generics 

A trio of legal experts discuss Amy Coney Barrett's bid for a Supreme Court seat and how that might affect deliberations on the Affordable Care Act and the Biologics Price Competition and Innovation Act (BPCIA).

Legal Experts Weigh in on BPCIA Severability

Years ahead of patent expirations for programmed death-1 (PD-1) inhibitors, biosimilar companies have begun focusing on these targeted drugs.

Interview: Understanding the Attraction for PD-1 Inhibitor Biosimilars

The US Public Interest Research Group (PIRG) contends AbbVie's patent thicket for Humira (adalimumab) will encourage anticompetitive practices by other manufacturers.

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