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The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

Biologic copycats are making a bigger impact on drug prices as U.S. regulators open the doors wider, and new guidance could ...

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 ...

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 ® ...

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, ...

In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara ® (ustekinumab) and Humira ® (adalimumab), bringing the total number of Stelara ® interchangeables to four, plus an ...

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 ...

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 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® ...