Center for Biosimilars®
WEBFind out the latest news on biosimilars, including approvals, market access, pricing, and research. Learn from experts and stakeholders on biosimilar trends, challenges, and opportunities.
FDA Approves Second Neupogen Biosimilar, Nivestym - Center for …
WEBJul 20, 2018 · Pfizer's filgrastim-aafi, a biosimilar to Amgen's Neupogen, has been approved by the FDA for the same indications as the reference product. The drug, sold as Nivestym, is the second filgrastim biosimilar in the US market …
FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
WEBJul 23, 2019 · Ruxience is a biosimilar of Rituxan, approved for certain indications of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and autoimmune diseases. The biosimilar was shown to have similar efficacy, safety, and …
FDA Approves Semglee Insulin Glargine as First Interchangeable …
WEBJul 29, 2021 · Semglee is a long-acting human insulin analog that can be substituted for Lantus by pharmacists without physicians' permission. It is the first interchangeable biosimilar approved by the FDA, which aims to increase …
FDA Approves Celltrion's Rituximab Biosimilar, Truxima
WEBNov 29, 2018 · The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs). The biosimilar, referencing Rituxan, has been approved to treat adults with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) either as monotherapy or in combination with chemotherapy.
Amgen Releases Positive Phase 3 Results for Stelara Biosimilar
WEBApr 19, 2022 · Amgen announced positive phase 3 results for its ustekinumab biosimilar (ABP 654) in patients with moderate to severe plaque psoriasis. The biosimilar candidate had comparable safety and efficacy to the reference product (Stelara), which is expected to lose patent protection in September 2023.
European Commission Approves Second Lucentis Biosimilar
WEBAug 29, 2022 · The European Commission (EC) granted marketing authorization to Teva Pharmaceuticals’ ranibizumab biosimilar (Ranivisio), the second ophthalmology biosimilar and the second biosimilar to reference Lucentis to be approved in the European Union (EU).
An Interview With the AAO About Its Bevacizumab Concerns
WEBAug 10, 2021 · This is a grey area where a battle is currently playing out in the field of ophthalmology. On one side is the American Academy of Ophthalmology (AAO), a group of 32,000 eye physicians and surgeons, and on the other are payers.
FDA Approves Third Trastuzumab Biosimilar, Ontruzant
WEBJan 19, 2019 · Kelly Davio contributed to this article. The FDA has approved Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer and HER2 overexpressing gastric cancer.
FDA Approves Amgen's Infliximab Biosimilar, Avsola - Center for …
WEBDec 6, 2019 · Avsola (infliximab-axxq) is a biosimilar of Remicade, a biologic drug for various inflammatory conditions. The FDA approved Avsola based on clinical trials showing its efficacy and pharmacokinetic similarity to Remicade.