FDA Approves Sandoz’ High-Concentration Version of …
Mar 21, 2023 · Sandoz said Tuesday the the FDA approved its citrate-free, high-concentration formulation (HCF) of its adalimumab biosimilar, Hyrimoz. The adalimumab-adaz injection (100 mg/mL) is approved to treat 7 indications covered by the reference product, Humira, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis ...
European Commission Approves First Aflibercept Biosimilar
Sep 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 ...
FDA Approves First Stelara Biosimilar, Wezlana - Center for …
Nov 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 ulcerative colitis.
Safety Findings Are Reported for Trastuzumab Biosimilars
Jun 21, 2021 · Those included diarrhea (4.11%), fatigue (3.66%), nausea (3.35%), weight decrease (2.74%), and infusion reactions (2.59%). “The AEs noted in patients with breast cancer and gastric cancer treated with biosimilar trastuzumab were consistent with the known safety profile of trastuzumab,” investigators said. Earlier findings from the study ...
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 ...
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 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 ...
Canada Approves High-Concentration Humira Biosimilar
Jan 3, 2023 · Samsung Bioepis announced the Canadian approval of its high-concentration (HC), citrate-free formulation of its biosimilar referencing Humira (adalimumab). Hadlima HC was developed through a commercialization agreement between Samsung Bioepis and Organon. The approval comes almost 4 years after Health Canada’s initial approval of the low-concentration version of Hadlima (SB5) in May 2018.
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 ...
FDA Approves Semglee Insulin Glargine as First Interchangeable …
Jul 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 is ...