Omlyclo is used for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, ...

Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars ...

Jay Bhattacharya, nominee for National Institutes of Health director, and FDA pick Marty Makary clear key Senate committee.

Regulatory reforms that improve the competitive landscape for biosimilars will promote drug affordability while incentivizing ...

Celltrion has launched Steqeyma (ustekinumab-stba), its biosimilar of Stelara (ustekinumab), at list price at an 85% discount ...

It has been 10 years since the first biosimilar was approved by the FDA. The grades on how the market for biosimilars has ...

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, ...

The FDA has approved Stoboclo (denosumab-bmwo), a biosimilar to Prolia (denosumab), and Osenvelt (denosumab-bmwo), a biosimilar to Xgeva (denosumab).

The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for ...

OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for ...

STEQEYMA®, one of the first-wave biosimilars to STELARA®, is now available in the U.S. Approved for the same indications as ...