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 …
FDA Approves First Subcutaneous Infliximab Product - Center for …
WEBOct 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 ...
Amgen Releases Positive Phase 3 Results for Stelara Biosimilar
WEBApr 19, 2022 · Article. A phase 3 study conducted by Amgen found that the company’s ustekinumab biosimilar was as safe and efficacious as the reference product (Stelara) in patients with moderate to severe plaque psoriasis. Amgen shared preliminary results from its phase 3 study showing that the company’s ustekinumab biosimilar (ABP 654) had …
FDA Approves First Denosumab Biosimilars - Center for Biosimilars
WEBMar 5, 2024 · The FDA has approved Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US. 1 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.. The FDA accepted Sandoz’ biologics license application for Wyost/Jubbonti in February 2023.
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 …
Center for Biosimilars®
WEBPart 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 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 …
Oncology | Clinical News & Insights - Center for Biosimilars
WEBSep 25, 2024 · Biosimilars Oncology Roundup: June 2024. Skylar Jeremias. July 2nd 2024. As the weather heats up for the US and Europe, so too did the biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
FDA Approves Fifth Pegfilgrastim Biosimilar, Fylnetra
WEBJun 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 …
Eli Lilly Launching Lower-Priced Authorized Generic of Its Insulin …
WEBMar 4, 2019 · Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price. The price of insulin has been top-of-mind for many lawmakers from both sides of the aisle, starting with a Senate ...