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.
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.
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.
BioRationality—The Evolution of the BPCIA and the Bright Future …
Oct 7, 2024 · The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have drastically reduced costs and approval times, with further advancements expected by 2025 that will foster competition and drive down prices.
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).
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.
Biosimilars Development Roundup: October 2024
Oct 31, 2024 · GRx+Biosims and Biosimilar Sustainability. At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, emphasized the urgent need for data transparency in the global supply chain and the crucial roles of collaboration and artificial intelligence (AI) in ensuring the resilience of biosimilar and generic drug production. 1 He noted that recent disruptions caused by hurricanes have ...
Biosimilar CT-P42 Demonstrates Equivalence to Aflibercept for DME
Aug 20, 2024 · Patients with diabetic macular edema (DME) displayed similar outcomes when treated with biosimilar candidate CT-P42 or reference aflibercept (Eylea) in terms of efficacy, with similar pharmacokinetic (PK), usability, safety, and immunogenicity profiles, according to a study published in Ophthalmology Retina. 1. Patients with diabetes often develop DME, a …
FDA Approves Avzivi, the Fifth Biosimilar to Avastin
Dec 19, 2023 · The FDA has approved the fifth bevacizumab biosimilar, Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn) for the treatment of several types of cancer.. Avzivi is a humanized monoclonal antibody that inhibits vascular endothelial growth factor and references Genentech’s Avastin (bevacizumab).
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 Wezlana an interchangeability designation.