Legal

Study: Machine Learning Could Optimize Biosimilar Therapy

January 12, 2021

Deana Ferreri, PhD

Article

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

CfB Board Members Reflect on Year in Biosimilars

December 28, 2020

Tony Hagen

Article

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.

Opinion: The Legal and Regulatory Year in Review

December 24, 2020

Stacie Ropka, JD, PhD

Article

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

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).

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