Center for Biosimilars®
WEBSeptember 24th 2024. Part 2 of our series diving into the Association for Accessible Medicines' (AAM) latest report discusses that while generics and biosimilars saved $445 billion in 2023, their potential is hindered by high patient costs, drug shortages, and ineffective policies, underscoring the need for reforms to fully realize their benefits.
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 …
FDA Approves Pfizer's Trastuzumab Biosimilar, Trazimera
WEBMar 12, 2019 · The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin. "This is an important milestone in the [United States] which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, global president of …
FDA Approves Samsung Bioepis' Etanercept Biosimilar, Eticovo
WEBApr 26, 2019 · Rheumatology (Oxford). doi: 10.1093/rheumatology/kex269. The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). A representative from Samsung Bioepis has confirmed approval of the product to The Center for Biosimilars® in an email. The biosimilar is already approved in a …
FDA Approves Celltrion Biosimilar for Avastin, Vegzelma
WEBSep 30, 2022 · The FDA approved Celltrion Healthcare’s Vegzelma (bevacizumab-adcd; CT-P16), a biosimilar referencing Genentech’s Avastin. The approval marks the fourth bevacizumab biosmilar to be approved in the United States. Additionally, Vegzelma is the second bevacizumab product, the fifth oncology biosimilar, and sixth biosimilar overall to be ...
First Rituximab Biosimilar, Truxima, Launches in the United States
WEBNov 7, 2019 · Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11. Truxima will be available at $845.55 for a 100-mg vial and $4227.75 for a 500-mg vial ...
FDA Releases Draft Guidance on Insulin Biosimilars, …
WEBNov 25, 2019 · Article. The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins. The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products ...
Infographic: Infliximab Biosimilars in the United States
WEBOct 1, 2017 · The FDA approved a new strength of a trastuzumab biosimilar; UnitedHealth will remove reference adalimumab from some preferred drug lists in favor of biosimilars and Evernorth will offer an interchangeable ustekinumab biosimilar at no cost to patients; Samsung Bioepis received a positive regulatory opinion for its aflibercept biosimilar.
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 First Stelara Biosimilar, Wezlana - Center for …
WEBNov 1, 2023 · The FDA approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference Stelara (ustekinumab). The biosimilar was also approved with an interchangeability designation. Stelara is an interleukin-12 and interleukin-23 antagonist used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and …