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 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.
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 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.
Future Biosimilar Trends, Challenges, and Opportunities
Sep 29, 2024 · Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center, discusses the evolvement of the biosimilar landscape throughout the …
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 neovascular age-related macular degeneration (nAMD) and was granted interchangeability, allowing it to be substituted in place of the reference product at the pharmacy level without provider permission.
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).
Biosimilar Policy Roundup—September 2024
Oct 1, 2024 · New Policy Updates and Considerations for the Future. The FDA has approved Pavblu (aflibercept-ayyh), the fifth biosimilar to Eylea (aflibercept), for treating retinal conditions such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Developed by Amgen, Pavblu's approval follows a series of approvals for other aflibercept biosimilars in 2024.
The Underlying Economics of Unbranded Biologics - Center for …
Feb 26, 2024 · Unbranded biologics primarily serve to uphold inflated list prices, typically prompted by loss of exclusivity, aiming to safeguard market share and counter biosimilar competition, although forthcoming legislative changes targeting high drug costs could lessen their significance moving forward.
Immunology - Center for Biosimilars
The 2023 European Alliance of Associations for Rheumatology (EULAR) recommendations for psoriatic arthritis (PsA) provide an evidence-based treatment strategy, prioritizing conventional and biological disease-modifying antirheumatic drugs, including biosimilars, tailored to disease manifestations, with an emphasis on safety, cost-effectiveness, and patient-centered care.