March 16th 2021
By Tony Hagen
"Shocked" by the threat of competition, originator manufacturers start raising prices long before rival products appear on the scene, investigators found.
March 11th 2021
By Deana Ferreri, PhD
Unsustainably low prices for generics are preventing some manufacturers from producing them, while biosimilars are blocked by policies that favor originator drugs, the Association for Accessible Medicines (AAM) argues.
December 28th 2020
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.
December 24th 2020
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.
November 24th 2020
GP2 peptide/G-CSF in HER2-equivocal and -positive breast cancer has shown promise.
November 19th 2020
Plans for a $453.3 million high volume plant and research center were unveiled during an industry forum this week in Republic of Korea.
November 18th 2020
The FDA's acceptance of the biologics license application (BLA) moves the companies one step closer to entering the US ophthalmology treatment sphere with a biosimilar.
November 17th 2020
The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.
November 10th 2020
The survival of the biosimilars approval pathway seemed on surer footing today following oral arguments at the Supreme Court over the Affordable Care Act and the severability of its provisions.
Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars (OTBB), highlighted the ways the FDA is working to remove blocks and wedges hindering biosimilars.
