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Tony Hagen is senior managing editor for The Center for Biosimilars

In part 2 of this year-end feature, we look at the most-read biosimilar stories of the second half of 2020. 

A Review of the Most-Read Biosimilar Stories of 2020: Part 2

MYL-14020 could have been the fourth US biosimilar approved by the end of 2020, but the FDA hasn't been able to complete a necessary foreign inspection, owing to the pandemic.

Pandemic Delays FDA Decision on Biocon's Bevacizumab Application

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

The top stories in biosimilars for 2020 encompassed biosimilar approvals and launches, the coronavirus disease 2019 pandemic, and the FDA's challenge to stay on top of the rapidly changing health care landscape. 

A Review of the Most-Read Biosimilar Stories in 2020: Part 1

Christophe Bourdon, senior vice president and general manager of US Oncology for Amgen, discussed the development and marketing plan for the company's newly approved rituximab biosimilar. 

Amgen's Bourdon Discusses Riabni Rollout in the United States

A partnership forum sponsored by the Academy of Managed Care Pharmacy (AMCP) yielded numerous ideas for improving access to biosimilars.

AMCP Sets a Course for Biosimilar Promotion

Building on regulatory submissions elsewhere, the company is looking to gain approval for bevacizumab candidate BAT1706 in Brazil.

Bio-Thera Seeks to Enter Brazilian Market for Bevacizumab

The Canada Health approval for Hyrimoz will be followed by a launch in February 2021, Sandoz Canada said.

Sandoz Canada Gains Marketing Approval for Adalimumab Biosimilar

The approval of the Amgen product marks the third biosimilar approval in the United States since the beginning of 2020. 

FDA Approves Rituximab Biosimilar "Riabni" From Amgen

An international group of physicians, surgeons, lawyers, scientists, and pharmacists weighs in on biosimilar policy differences and deficiencies in the United States, Europe, and Japan.  

Regulatory