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 Johnson & Johnson's annual financial report.It’s also 1 of the first 10 medications selected by CMS for drug price negotiation, which will go into effect at the start of 2026.
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 The approval covers Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Ustekinumab is a human monoclonal antibody targeting IL-12 and IL-23.
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 2024, beginning with Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis' Opuviz (aflibercept-yszy) in May 2024, followed by Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb) in July 2024 and Enzeevu. 3,4
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 (ustekinumab-aekn), Imuldosa (ustekinumab-srlf), and Pyzchiva (ustekinumab-ttwe).
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 osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.. The FDA accepted Sandoz’ biologics license application for Wyost/Jubbonti in February 2023.
FDA Approves Samsung Bioepis’ Pyzchiva, a Biosimilar to Stelara
Jul 1, 2024 · Pyzchiva marks the third biosimilar referencing Stelara (ustekinumab) to be approved for the American market, and the biosimilar was approved with an interchangeability designation, allowing for it to be substituted for the reference product at the pharmacy level without waiting for physician approval.
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 allows for the subcutaneous administration of its infliximab biosimilar (Inflectra, Remsima).
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 (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce), the last of which was approved at the beginning of December 2024. 3 ...
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 development is based on Remicade (reference intravenous infliximab).
Future Biosimilar Trends, Challenges, and Opportunities
Sep 29, 2024 · Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.