Regulatory

Wayne Winegarden, PhD: The Most Important Factor for Understanding Biosimilar Prices

January 2nd 2022

By Skylar Jeremias

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, explains pricing issues for reference drugs and biosimilars.

Report: Biosimilar Competition in Europe

January 1st 2022

By Tony Hagen

Biosimilars have produced more than $20 billion of savings in Europe, but more use of these agents is needed.

Rezvoglar Broadens Insulin Glargine Biosimilar Options

December 30th 2021

With an FDA approval for a second insulin glargine biosimilar, the stage is set for stronger competition in 2022 with potential improved access and savings for patients.

Biosimilar Legal and Business Developments in 2021

December 27th 2021

By Skylar Jeremias

The Center for Biosimilars® spoke recently with Chad Landmon, chair of the Intellectual Property and Food and Drug Administration Practice Groups at Axinn, a New York–based antitrust, intellectual property, and litigation law firm.

Wayne Winegarden, PhD, Evaluates Possible Impact of Adalimumab, Etanercept Biosimilars

December 26th 2021

By Skylar Jeremias

Wayne Winegarden, PhD, discusses his savings analysis for adalimumab and etanercept biosimilars and their potential market share.

Lannett Seeks to Begin Insulin Glargine Biosimilar Trial

December 25th 2021

Lannett hopes to initiate a pivotal trial of its insulin glargine biosimilar candidate, in anticipation of a launch in 2024.

The Top 5 Biosimilar Regulatory Stories of 2021

December 22nd 2021

From the approval of the first insulin glargine biosimilar (Semglee) to the potential for extreme biosimilar competition in the adalimumab market, 2021's regulatory stories were popular with readers.

2021 Was an "Inflection Year" for Biosimilars

December 21st 2021

By Tony Hagen

The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.

FDA Approves Yusimry, the Seventh Adalimumab Biosimilar

December 21st 2021

By Tony Hagen

Coherus BioSciences said the 40 mg subcutaneous formulation of adalimumab would be launched on or after July 1, 2023, in agreement with AbbVie, maker of Humira, the reference product.

Panelists Discuss Regulatory Perspective on Biosimilars

December 20th 2021

By Tony Hagen

A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.