Center for Biosimilars®
WEBSarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.
FDA Approves Third Trastuzumab Biosimilar, Ontruzant
WEBJan 19, 2019 · 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. The drug was first approved by the European Medicines Agency in November 2017, making it the first biosimilar trastuzumab to be approved in ...
Teva Announces US Launch of Lenalidomide, Generic of Revlimid
WEBMar 8, 2022 · Teva Pharmaceuticals on Monday launched lenalidomide capsules, the generic of Revlimid, in the United States. The capsules are available in 5 mg, 10 mg, 15 mg, and 25 mg strengths, according to a statement from the company. Lenalidomide is used in regimens to treat multiple myeloma, mantle cell lymphoma, and …
Zydus Cadila Launches Trastuzumab Emtansine Biosimilar
WEBMay 24, 2021 · The originator trastuzumab emtansine (Kadcycla) was developed by Genentech, a subsidiary of Roche. Zydus Cadila said it would market the biosimilar version “at nearly 80% less than” the originator product. An antibody conjugate, Ujvira combines the cancer cell growth–fighting properties of trastuzumab with the cytotoxic capability of ...
FDA Approves Semglee Insulin Glargine as First Interchangeable …
WEBJul 29, 2021 · The FDA has approved Biocon Biologic's Semglee insulin glargine as an interchangeable biosimilar, referencing Lantus. The approval carries with it many hopes for stronger competition in the insulin market, which is dominated by a handful of brands and characterized by stubbornly high prices. The approval of Semglee was much anticipated; it …
News - Center for Biosimilars
WEBSep 23, 2024 · AAM Report: Generics and Biosimilars Savings Reach $445 Billion in 2023, Part 1. Savings from generic and biosimilar drugs totaled $445 billion in 2023, showing promise for the growth of both markets and highlighting the success of expansion policies for these products, according to a new report from …
Amgen 2020 Biosimilar Report Provides Market Share, ASP Info
WEBOct 14, 2020 · Retacrit now has a 25% share of the market for epoetin alpha vs 18% for Procrit and 57% for Epogen. In the US infliximab market, 3 biosimilars have been marketed, including Avsola (July 2020). The ASP for reference Remicade has dropped to 33% below its pre-biosimilar cost, and the ASPs for Renflexis and Inflectra currently stand at …
Trastuzumab-qyyp Maintains Stability and Potency Under …
WEBMar 15, 2022 · Researchers using “a range of structural analytical techniques and a functional bioassay” found that biosimilar trastuzumab-qyyp is stable and maintains its biological activity under extended in-use conditions. They said that the findings, which were published in the Journal of Oncology Pharmacy Practice, are consistent with results from ...
FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
WEBJul 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 …
European Commission Approves First Aflibercept Biosimilar
WEBSep 21, 2023 · The approval came after the EMA’s Committee for Medicinal Products for Human Use gave a positive opinion for the drug in July 2023, and it was the first aflibercept biosimilar to receive a thumbs up from the division. The news also came after Biocon published its quarterly earnings report, which showed that the company’s biosimilar global sales rose 106% compared with the same quarter the ...