All News

Alvotech Breaks Ground for Biosimilar Development Facility

January 3, 2021

Tony Hagen

Article

An expansion of its Reykjavik, Iceland, headquarters operation will speed the company on its way to launching its first biosimilars, officials said.

Reviewers Consider "Totality of Evidence" for Mvasi

January 2, 2021

Deana Ferreri, PhD

Article

Providers should feel confident using Mvasi, a bevacizumab biosimilar, for all indications of the reference product (Avastin), reviewers stated.

Innovent Biologics Gains NMPA Approval for Additional Sulinno Indications

December 31, 2020

Tony Hagen

Article

China's National Medical Products Administration (NMPA) has cleared Innovent Biologics' adalimumab biosimilar for more indications.

The Leading “Not So Different” Podcast Episodes of 2020

December 30, 2020

Video

Here are some of our most-listened-to 2020 "Not So Different" podcasts.

Opinion: The Year Ahead in Biosimilar Potential

December 29, 2020

Tony Hagen

Article

Many firsts may be in store for the biosimilar industry in 2021, although it will be dogged by ongoing difficulties, Center for Biosimilars® Advisory Board members said.

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.

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.

The Most-Popular Center for Biosimilars® Interviews of 2020

December 26, 2020

Video

Here are some of our most-popular biosimilar interviews for all 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.

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.

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