Blog
RSS FeedPosted by Michael Wonder on 20 Dec 2019
Amgen and Allergan submit biologics license application for ABP 798, biosimilar candidate to Rituxan (rituximab), to U.S. FDA
19 December 2019 - Filing for ABP 798 supported by two comparative clinical studies. ...
Posted by Michael Wonder on 18 Dec 2019
Statement from Anna Abram, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on low-cost biosimilar and interchangeable protein products
17 December 2019 - Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is ...
Posted by Michael Wonder on 11 Dec 2019
Biosimilar stakeholders praise removal of biologic exclusivity provisions from USMCA
11 December 2019 - An agreement on the United States–Mexico–Canada Agreement, a trade deal that updates the North American Free ...
Posted by Michael Wonder on 06 Dec 2019
FDA approves Amgen's Avsola (infliximab-axxq), for the same indications as Remicade (infliximab)
6 December 2019 - Amgen's fourth FDA approval from biosimilars portfolio. ...
Posted by Michael Wonder on 25 Nov 2019
Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
25 November 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes. ...
Posted by Michael Wonder on 19 Nov 2019
FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate
19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...
Posted by Michael Wonder on 18 Nov 2019
FDA approves Pfizer's biosimilar, Abrilada (adalimumab-afzb) for multiple inflammatory conditions
18 November 2019 - Pfizer today announced the United States FDA has approved Abrilada (adalimumab-afzb), as a biosimilar to Humira ...
Posted by Michael Wonder on 18 Nov 2019
Statement from Sarah Yim, acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
15 November 2019 - Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. ...
Posted by Michael Wonder on 09 Nov 2019
Teva and Celltrion announce the availability of Truxima (rituximab-abbs) injection, the first biosimilar to Rituxan (rituximab) in the United States
7 November 2019 - Truxima available week of November 11. ...
Posted by Michael Wonder on 06 Nov 2019
Is the FDA doing enough to bring biosimilars to market?
4 November 2019 - As the number of biosimilar approvals continues to rise in the US, the number of biosimilar ...
Posted by Michael Wonder on 05 Nov 2019
Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez)
5 November 2019 - Ziextenzo is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects ...
Posted by Michael Wonder on 23 Oct 2019
Adalimumab and the challenges for biosimilars
23 October 2019 - Biologic drugs are expensive therapeutic agents and represent a large and growing segment of pharmaceutical spending. ...
Posted by Michael Wonder on 07 Oct 2019
Pfenex receives U.S. FDA approval for PF708 to treat osteoporosis
7 October 2019 - Comparative human factors study report expected to be submitted to FDA as early as the second half ...
Posted by Michael Wonder on 12 Sep 2019
Draft Pelosi plan targets drugs lacking biosimilar or generic option
12 September 2019 - While chances of her leaked plan to force lower drug prices in the United States getting through ...
Posted by Michael Wonder on 12 Sep 2019
In U.S. biosimilars run into more roadblocks
12 September 2019 - In a recent op-ed in the Wall Street Journal Peter Bach asks whether it's time to ...