It is the first tocilizumab biosimilar approved by the FDA. The reference product, Actemra (Genentech), was first approved by the agency in 2010. "The approval of Tofidence in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to lead...
All FDA-approved biosimilar products meet the FDA’s strict standards for approval. Patients and health care providers can rely on the safety and effectiveness of the biosimilar or interchangeable product just as they would for the reference product, according to the agency.1 ...
The company also said the approval builds upon its record of bringing biosimilars to the market, such as the first interchangeable insulin, Semglee, the first biosimilar Trastuzumab, Ogivri, and the first biosimilar pegfilgrastim, Fulphila, to patients in the United States. Samsung Bioepis and Biog...
351(a)确立生物制品上市的基本要求和审批的基本原则, 351 (i)定义了什么是"biological product"、"biosimilar"、"interchangeable"、"reference product", 351(k)确立了生物类似物的简化程序审批原则和上市途径。 根据PHS法案第351(a)节,提交的申请是“独立”申请,并且必须包含证明拟议产品安全、纯度和有效(安全有效)...
新药批准(New Drug Approval):针对新药的申请,FDA进行全面的审查和评估,以确定其安全性和有效性,并批准其在市场上销售和使用。 生物类似药物(Biosimilar)认证:针对生物类似药物的申请,FDA进行比对研究和评估,以确定其与参比药物的相似性,从而获得认证并获准上市。
FDA APPROVES FIRST BIOSIMILAR.The article reports on the approval of the first biosimilar product called Zarxio from Sandoz by the U.S. Food and Drug Administration (FDA) as a less expensive alternative to Neupogen from Amgen Inc. for boosting white blood cells in cancer patients.ERICKSON...
The first biosimilar, ustekinumab-auub (Wezlana; Amgen), was approved in October 2023 and has a product launch date of no later than January 1, 2025, according to the Center for Biosimilars.2-4 The approval was based on an evaluation of a data package that included analytical, pre-...
the the U.S. Food and Drug Administration (FDA)approved Jubbonti (denosumab-bbdz, 60 mg/1 mL injection), as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz, 120 mg/1.7 mL [70 mg/mL] injection), as an interchangeable biosimilar to U.S.-...
"It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products," said Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff in the FDA'...
The FDA granted approval to Samsung Bioepis based on the totality of the evidence, including robust clinical studies confirming that Pyzchiva® has equivalent efficacy and comparable safety as its reference medicine. Sandoz entered into a development and commercialization agreement for biosimilar ustekinum...