Legal

Biosimilar Legal Roundup: November 2020

November 30, 2020

Skylar Jeremias

Article

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.

EC Eyes Enhancements for a Post–COVID-19 Marketplace

November 27, 2020

Tony Hagen

Article

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.

Biosimilars Forum Chooses Director With Democratic Influence

November 23, 2020

Tony Hagen

Article

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

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

November 17, 2020

Tony Hagen

Article

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

Genentech Files to Block Marketing of Centus' Bevacizumab Biosimilar

November 17, 2020

Tony Hagen

Article

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

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

November 16, 2020

Article

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.

Legal Opinion: BPCIA Is Likely to Survive Latest ACA Challenge

November 11, 2020

Chad Landmon, JD

Article

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).

Supreme Court Hints Biosimilar Route Might Be Preserved

November 10, 2020

Tony Hagen

Article

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.

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

November 5, 2020

Tony Hagen

Article

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.

Legal Experts Weigh in on BPCIA Severability

October 26, 2020

Tony Hagen

Article

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).

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