Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2019
First biosimilar of dornase alfa inhalation solution for CF approved in Russia, companies announce
19 September 2019 - A biosimilar of dornase alfa inhalation solution, with the same therapeutic activity as Pulmozyme, its reference ...
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 11 Sep 2019
Biosimilar and interchangeable: inseparable scientific concepts?
4 September 2019 - As defined by the European Commission, the term interchangeability refers to “the possibility of exchanging one medicine ...
Posted by Michael Wonder on 11 Sep 2019
Canada OKs Celltrion's biosimilar
10 September 2019 - Celltrion said that Health Canada has given the go-ahead for Herzuma (trastuzumab), an anticancer antibody biosimilar, ...
Posted by Michael Wonder on 10 Sep 2019
Erosion of physician and patient treatment choice continues - Alliance for Safe Biologic Medicines raises concerns for patients as British Columbia expands biologics forced switching policy
10 September 2019 - On 5 September, the Government of British Columbia announced that it would be forcibly switching 1,700 patients ...
Posted by Michael Wonder on 04 Sep 2019
Health Canada updates its biosimilar fact sheet
4 September 2019 - Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key ...
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 02 Sep 2019
Dutch experience demonstrates effective benchmarking of biosimilar use in health systems
31 August 2019 - As medicines become more numerous and often more expensive, health care professionals seek new ways to understand ...
Posted by Michael Wonder on 29 Aug 2019
EMA offers edits on FDA draft guidance on biosimilars
29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...
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. ...