This number has risen dramatically (40 approvals), with a total of 22 cancer or cancer-related biosimilar products approved since 2015. Recently, the FDA also approved the four interchangeable biosimilar products for diabetes, certain inflammatory diseases, and certain ophthalmic diseases. Given the ...
According to the FDA,Bkemvis a monoclonal antibody that inhibits activation of the complement system by binding to the complement C5 protein. This inhibition prevents the intravascular hemolysis in patients with these rare conditions. This approval and interchangeable designation mean that provi...
In March 2020 most protein products that were approved as drug products (including every insulin currently on the market) will open up to biosimilar and interchangeable competition. However, “chemically synthesized polypeptides” are excluded from this transition, which means that ...
"This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs," said Acting FDA Commissioner Janet Woodcock, M.D. "Today's approval of the fi...
vi “Biosimilar and Interchangeable Products.” U.S. Food and Drug Administration website. Oct 23, 2017. Available at: https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Accessed September 2021. vii IQVIA Institute for Human Data Science. Biosimilars in the United States...
The FDA released newmaterials for health care providersregarding biosimilar and interchangeable biosimilar products, including afact sheetabout interchangeable biosimilar products. Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with...
The FDA approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications: Adult patients with: moderate to severe plaque psoriasis who are ca...
Biosimilar and Interchangeable Products. Available at: https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Accessed August 2022. 5 IQVIA Institute for Human Data Science. (October 2020). “Biosimilars in the United States 2020–2024.”...
FDA’s high standards for approval of interchangeable products are intended to assure patients and health care providers that they can have confidence in the safety and effectiveness of an interchangeable product, just as they would for an FDA-approved reference product, Dr. Hurvitz noted. ...
EMA此前并没有刻意地要求互换性(interchangeable),而是由各个成员国的监管机构自行决定是否可以替代,直到2022年9月,EMA才发文声明,称凡是其批准的biosimilar均可互换使用。因为不要求互换性,所以EMA对biosimilar的审批相对灵活,快速批准了多个产品,截止2023年5月,EMA已经批准了76个biosimilar,涉及19种生物制品[2]。