Fourth Ustekinumab Biosimilar, Otulfi, Approved in US
Sep 30, 2024 · The FDA has approved the fourth ustekinumab biosimilar, ustekinumab-aauz (Otulfi) from Formycon and Fresenius Kabi, referencing Stelara (Johnson & Johnson [J&J]). 1 …
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 …
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 …
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 Biosimilar Enzeevu for Eye Conditions
Aug 12, 2024 · 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 …
FDA Approves First Subcutaneous Infliximab Product - Center for …
Oct 23, 2023 · The FDA approved Celltrion USA’s Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product. Zymfentra is approved as a novel drug, and its …
Celltrion, Samsung Bioepis Unveil New Biosimilar Data in CD, UC …
ECCO 2024 took place from February 21 to February 24, 2024, in Stockholm, Sweden. Updated Celltrion Data on Subcutaneous Infliximab Therapy 1. Celltrion shared long-term data from its …
Addressing Hesitance in Biosimilar Adoption
Oct 20, 2024 · In an interview, Sophia Humphreys, PharmD, discusses how the expansion of biosimilars into new therapeutic areas, such as immunology, endocrinology, and …
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 …
IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars …
Oct 14, 2024 · During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the …