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.
Novo Nordisk Launches Authorized Generic Insulins, Gets FDA …
WEBJan 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FDA Issues Draft Guidance Q&A on Biosimilar Interchangeability ...
WEBDec 2, 2020 — The FDA recently released a new draft guidance document to clarify submission procedures for applicants looking to gain licensing for a product seeking to be designated as an interchangeable biosimilar. The question-and-answer document provides guidance for applicants as they formulate their submission documents in order to …
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 …
Supportive Care in Oncology Therapy: Pegfilgrastim Biosimilars in …
WEBDec 7, 2016 — Although filgrastim-sndz (Zarxio ®) was launched for use as a supportive care treatment about 1 year ago, the pegylated version (pegfilgrastim) Neulasta ® is, by far, the more commonly prescribed agent. This agent has a significantly longer half-life than its predecessor and is the preferred agent in patients receiving cancer chemotherapy.
Bio-Thera Moves Golimumab Candidate Into Phase 3 Trial
WEBJun 8, 2021 — Bio-Thera has set up a psoriatic arthritis clinical trial for BAT2506, which references Simponi. Guangzhou, China–based Bio-Thera Solutions has initiated a phase 3 clinical study for its golimumab biosimilar candidate (BAT2506) referencing Simponi. The double-blind, randomized, parallel, control study will compare the efficacy and safety of ...
Rituximab Biosimilars Effective in Treating Immune …
WEBJan 15, 2024 — A French study found that rituximab biosimilars, Rixathon and Truxima, were as effective and safe as the reference drug (Rituxan) in treating immune thrombocytopenia. Two rituximab biosimilars (Rixathon and Truxima) and the reference drug (Rituxan) exhibited similar safety and efficacy outcomes in patients with …
Stelara and Enbrel Chosen for IRA Price Negotiation
WEBAug 29, 2023 — Etanercept biosimilars are expected to launch in 2029 and ustekinumab biosimilars have been delayed from 2023 to 2025 after biosimilar manufacturers settled patent litigation suits with the originator manufacturer, Janssen. Additionally, while the European Union has 3 insulin aspart biosimilars on the market, the United States has none. According to the announcement of the list, the first 10 ...
Biogen to Sell Its Stake in the Biosimilar Venture Samsung Bioepis
WEBJanuary 28, 2022. By Laura Joszt. Article. In a deal to sell the 50% ownership stake, Biogen would receive up to $2.3 billion. In 2012, Biogen invested a 15% stake in Samsung Bioepis and then increased ownership up to 50% less 1 share in June 2018. However, it’s now extracting itself from the biosimlar joint venture with Samsung Biologics.
Amgen Discusses Interchangeable Status for Its Adalimumab …
WEBNov 8, 2021 — The company said it has a trial under way to help qualify Amjevita for interchangeable status, which would allow pharmacists to substitute the product for reference brands. The product brought in $111 million in revenues in the quarter just ended, up from $80 million a year earlier. Biosimilars contributed to …