January 5th 2022
By Tony Hagen
The companies hope to gain FDA approval for a high-concentration, citrate-free version of Hadlima, an adalimumab biosimilar that was approved in a lower concentration in July 2019.
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.
January 1st 2022
Biosimilars have produced more than $20 billion of savings in Europe, but more use of these agents is needed.
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.
December 27th 2021
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.
December 26th 2021
Wayne Winegarden, PhD, discusses his savings analysis for adalimumab and etanercept biosimilars and their potential market share.
December 25th 2021
Lannett hopes to initiate a pivotal trial of its insulin glargine biosimilar candidate, in anticipation of a launch in 2024.
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.
December 21st 2021
The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.
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.
