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RSS FeedPosted 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 ...
Posted by Michael Wonder on 11 Sep 2019
We need to make biosimilars easier to get
11 September 2019 - If potential biosimilar manufacturers can’t get their product to market, they won’t proceed with development. ...
Posted by Michael Wonder on 03 Sep 2019
Mylan and Biocon get a second complete response letter for insulin glargine follow-on
3 September 2019 - Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second ...
Posted by Michael Wonder on 02 Sep 2019
Biosimilars Forum’s public letter in response to anti-biosimilars Op-Ed
29 August 2019 - Government Should Not “Throw In the Towel on Biosimilars,” They Should Act Now to Unlock Billions ...
Posted by Michael Wonder on 27 Aug 2019
Congress should be promoting, not discouraging, the development of biosimilars
27 August 2019 - Drug prices continue to dominate the headlines, yet many of the policy ideas being considered in ...
Posted by Michael Wonder on 27 Aug 2019
We need a more rational biosimilars policy
27 August 2019 - Throwing in the towel on a whole new category of medicines, just shy of a decade in, ...
Posted by Michael Wonder on 26 Aug 2019
Don’t give up on biosimilars—Congress can give them a boost
25 August 2019 - Drugs grown in live cells are hard to replicate. But policy changes can help accelerate the process. ...