November 30, 2020
Skylar Jeremias
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.
November 27, 2020
Tony Hagen
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.
November 23, 2020
Meaghan Rose Smith's appointment comes during a time of challenges for the biologics industry.
November 17, 2020
Despite a rocky power transition at the federal level, the compass heading for biosimilars is unchanged, said policy expert Molly Burich.
The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.
November 16, 2020
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.
November 11, 2020
Chad Landmon, JD
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).
November 10, 2020
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.
November 5, 2020
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.
October 26, 2020
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).
