2024年12月18日 · The approval represents the seventh biosimilar approval for a Stelara competitor. 2 Steqeyma follows Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), …

2024年10月11日 · Stelara is one of the highest-grossing biologics in the US, generating $10.86 billion globally in 2023. Additionally, US sales for Stelara reached $6.4 billion in 2022, …

2024年11月7日 · During the discussion, panelists emphasized the need for greater transparency and policy reforms within PBM practices to improve biosimilar access and competition. 16 The …

2024年9月17日 · Pavblu was developed by Amgen and comes shortly after the FDA approved Enzeevu (aflibercept-abzv) in August 2024. 2 All 5 aflibercept biosimilars were approved in …

2024年3月5日 · The FDA has approved Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US. 1 The drugs will be used to treat …

2024年11月6日 · Currently, Celltrion USA has 6 biosimilars (infliximab, rituximab, trastuzumab, adalimumab, bevacizumab, on the US market, as well as Zymfentra, a novel product that …

2024年2月24日 · After receiving 3 complete response letters, Alvotech has officially received US approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first approval for the …

2024年12月2日 · The biosimilar was developed by Karnataka, India–based Biocon Biologics and will likely launch in the second half of 2025, along with Otulfi (ustekinumab-aauz), Selarsdi …

2024年12月25日 · In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars …

2024年8月12日 · Sandoz secured another approval, this time for an aflibercept biosimilar. 1 Enzeevu (aflibercept-abzv) is the fourth biosimilar referencing Eylea and is approved to treat …