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). The intravenous version of Zymfentra is marketed as Inflectra (also, infliximab-dyyb), Celltrion's ...
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 · In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists. Dr Chelsee Jensen Speaks on How Health Systems Can Build Confidence in Biosimilars.
Novo Nordisk Launches Authorized Generic Insulins, Gets FDA …
Jan 7, 2020 · Novo Nordisk said 3 measures to make insulin more affordable are now available, and it also announced that the FDA expanded use of its fast-acting mealtime insulin to children as young as 2.
FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
Jul 23, 2019 · This article has been updated. The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. The fact that the biosimilar was not approved for all ...
Despite Steep Discounts, Humira Biosimilars Are Priced ...
Jul 17, 2023 · Despite significant discounts from the current price of Humira (adalimumab), the launch prices of some adalimumab biosimilars are still double the launch price of the originator, according to a study published in JAMA Network Open. Humira can be administrered in a prefilled syringe or autoinjector pen. Throughout 2023, 9 FDA-approved adalimumab ...
FDA Approves Fifth Pegfilgrastim Biosimilar, Fylnetra
Jun 1, 2022 · The FDA approved Fylnetra, the fifth approval for a pegfilgrastim biosimilar in the United States. The FDA has approved the fifth pegfilgrastim biosimilar for the US market, Amneal Pharmaceuticals and Kashiv Biosciences’ Fylnetra (pegfilgrastim-pbbk), referencing Neulasta. Fylnetra is the third biosimilar developed by Amneal Pharmaceuticals ...
The Hatch-Waxman Act Turns 40: The Law That Made ...
Feb 8, 2024 · Panelists emphasized the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars. To mark the 40th anniversary of the Hatch-Waxman Act, the Association for Accessible Medicines published a white paper outlining the benefits and ...
FDA Green Lights Second Tocilizumab Biosimilar - Center for …
Mar 7, 2024 · In September 2023, Biogen and Bio-Thera Solutions' Tofidence (tocilizumab-bavi) became the first biosimilar referencing Actemra (tocilizumab) to receive FDA approval.However, it was only approved for IV administration. “Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. is a ...
Samsung Bioepis’ Stelara Biosimilar Proves Successful in Phase 1 …
Mar 20, 2023 · Samsung Bioepis’ Stelara Biosimilar Proves Successful in Phase 1 Study. March 20, 2023. By Skylar Jeremias. Article. Conference | American Academy of Dermatology. At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a phase 1 study comparing its ustekinumab biosimilars (SB17) with the reference ...