FDA Approves Steqeyma: The Seventh Stelara Biosimilar
Dec 18, 2024 · The approval represents the seventh biosimilar approval for a Stelara competitor. 2 Steqeyma follows Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi …
FDA Approves Imuldosa, a Biosimilar to Stelara
Oct 11, 2024 · 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, according to …
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar …
Nov 7, 2024 · During the discussion, panelists emphasized the need for greater transparency and policy reforms within PBM practices to improve biosimilar access and competition. 16 The …
Breaking Down Biosimilar Barriers: The Patent System
Nov 11, 2024 · Patent litigation is often resource intensive on both sides. During an interview with The Center for Biosimilars, Ha Kung Wong, JD, an intellectual property attorney and partner at …
FDA Approves Pavblu for Retinal Conditions
Sep 17, 2024 · 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 …
FDA Approves First Denosumab Biosimilars - Center for Biosimilars
Mar 5, 2024 · 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 …
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves …
Dec 10, 2024 · Alvotech and Advanz Pharma have submitted a European marketing application for its golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean …
Celltrion Sets Sights on 2030 With Expanded Biosimilar Portfolio ...
Nov 6, 2024 · Currently, Celltrion USA has 6 biosimilars (infliximab, rituximab, trastuzumab, adalimumab, bevacizumab, on the US market, as well as Zymfentra, a novel product that …
FDA Approves First Stelara Biosimilar, Wezlana - Center for …
Nov 1, 2023 · The FDA approved Wezlana (ustekinumab-auub), making it the first approval for a biosimilar referencing blockbuster drug Stelara (ustekinumab). The agency also granted …
FDA Approves Biocon Biologics Ustekinumab Biosimilar, Yesintek
Dec 2, 2024 · 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 …