For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

The Food and Drug Administration has approved five biosimilars since 2010 — none of which are designated as “interchangeable” to the biologic drug they mimic, reports Regulatory Focus. The FDA defines ...

The letter was sent to Sens Cassidy, M.D. (R-La.) and Sanders (I-Vt.), chair and ranking member of the Senate Health ...

Findings showed equivalent efficacy in change from baseline in weekly itch severity score between omalizumab-igec 300mg and Xolair 300mg. The Food and Drug Administration (FDA) has approved Omlyclo ® ...

Please provide your email address to receive an email when new articles are posted on . Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co.), a HER2 receptor antagonist and biosimilar to ...

Please provide your email address to receive an email when new articles are posted on . Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis). Omlyclo was ...

The Biosimilars Council applauded the bipartisan introduction of the Biosimilar Red Tape Elimination Act in the U. S. House of Representatives. The legislation, sponsored by Representatives Pfluger (R ...

Evernorth Health Services, a subsidiary of Cigna, plans to have a Stelara biosimilar available for $0 out-of-pocket cost for eligible patients of its specialty pharmacy, Accredo, beginning in early ...

RIDGEFIELD, Conn., Oct. 2, 2023 /PRNewswire/ -- Boehringer Ingelheim announced today that Adalimumab-adbm injection, the company's interchangeable* biosimilar to Humira ® (adalimumab), is now ...

The expanded interchangeability now applies to the 40mg prefilled syringe and the 40mg and 80mg autoinjectors, in addition to the 20mg and 80mg prefilled syringes. The Food and Drug Administration ...

EAGAN, Minn., Nov. 3, 2021 /PRNewswire/ -- Prime Therapeutics LLC (Prime), a leading pharmacy benefit manager (PBM) serving nearly 33 million members, will be preferring Viatris' biosimilar Semglee® ...