Regulatory

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

December 27, 2020

Tony Hagen

Article

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

Pandemic Delays FDA Decision on Biocon's Bevacizumab Application

December 26, 2020

Tony Hagen

Article

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.

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.

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

December 24, 2020

Tony Hagen

Article

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.

Amgen's Bourdon Discusses Riabni Rollout in the United States

December 23, 2020

Tony Hagen

Article

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.

AMCP Sets a Course for Biosimilar Promotion

December 22, 2020

Tony Hagen

Article

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

Bio-Thera Seeks to Enter Brazilian Market for Bevacizumab

December 20, 2020

Tony Hagen

Article

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

Sandoz Canada Gains Marketing Approval for Adalimumab Biosimilar

December 18, 2020

Tony Hagen

Article

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

FDA Approves Rituximab Biosimilar "Riabni" From Amgen

December 17, 2020

Tony Hagen

Article

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

Policy Review Cites Need for Regulatory Clampdown on Pay-for-Delay Tactics

December 17, 2020

Deana Ferreri, PhD

Article

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.

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