Celltrion today announced the U.S. launch of STEQEYMA��(ustekinumab-stba), a biosimilar to STELARA� (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024.

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

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

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 ...

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

Amneal Pharmaceuticals (AMRX) “announced that the FDA has accepted for review its Biologics Licensing Application for two proposed denosumab ...

(Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and mAbxience ("mAbxience") today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its ...

Patients with non-small cell lung cancer (NSCLC) taking bevacizumab biosimilars demonstrated equivalent therapeutic efficacy and similar safety profiles to those taking the originator product, Avastin ...

As biosimilar versions of a big-selling Johnson & Johnson medicine reach the U.S. market, the health care giant accused one manufacturer of striking a “surreptitious” deal that could arguably ...

The launch marks a significant move, as YESINTEK is among the first biosimilar alternatives to Stelara (ustekinumab) to enter the US market. YESINTEK is approved for Crohn’s disease, ulcerative ...

INCHEON, South Korea I February 23, 2025 I Celltrion today announced that the European Commission (EC) has granted marketing authorization for Avtozma ® (CT-P47), a biosimilar referencing RoActemra ® ...