Fourth Ustekinumab Biosimilar, Otulfi, Approved in US
2024年9月30日 · 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 First Subcutaneous Infliximab Product - Center for …
2023年10月23日 · 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).
Despite Steep Discounts, Humira Biosimilars Are Priced More Than ...
2023年7月17日 · Throughout 2023, 9 FDA-approved adalimumab biosimilars are projected to enter the US market. As of the second week of July 2023, 8 had entered the market, beginning with Amgen’s Amjevita (adalimumab-atto) in January. Amjevita launched with a dual price strategy, where 2 versions of the drug would launch at 2 different prices (5% and 55% lower than the current price of Humira) to both entice ...
Stable Patient Satisfaction Found After Switching From the Humira …
2024年12月14日 · A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation. More patients previously treated with an adalimumab biosimilar compared with the reference product reported increased satisfaction after switching.
FDA Approves Imuldosa, a Biosimilar to Stelara
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, 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.
FDA Approves Pavblu for Retinal Conditions
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, 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 First Denosumab Biosimilars - Center for Biosimilars
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 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.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast …
2024年12月9日 · The proposed pertuzumab biosimilar QL1209 is equivalent in efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, according to a phase 3 study. 1 “QL1209 emerges as an effective biosimilar, offering a cost-effective alternative that may alleviate financial burdens and significantly contribute to ...
GRx+Biosims: Panelists Discuss Regulatory Shifts in Biosimilar ...
2024年10月22日 · At the GRx+Biosims 2024 conference, panelists explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.
Future Biosimilar Trends, Challenges, and Opportunities
2024年9月29日 · 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.