Blog
RSS FeedPosted by Michael Wonder on 19 Oct 2018
AbbVie announces global resolution of Humira (adalimumab) patent disputes with Fresenius Kabi
18 October 2018 - Agreements provide non-exclusive license to Fresenius Kabi for Humira related intellectual property in the U.S. effective 30 ...
Posted by Michael Wonder on 27 Sep 2018
Samsung Bioepis’ biologics license application for SB5 adalimumab biosimilar candidate accepted for review by the U.S. FDA
27 September 2018 - The biologics license application for SB5 was based on a 52 week Phase 3 study comparing SB5 ...
Posted by Michael Wonder on 26 Sep 2018
Mylan and Novartis to FDA: where are the suffixes?
26 September 2018 - Mylan and Novartis are taking issue with the fact that the US FDA has yet to ...
Posted by Michael Wonder on 04 Sep 2018
Biosimilar medicines are the key to success
3 September 2018 - The lives of more than 10 million Americans — those with rheumatoid arthritis, psoriatic arthritis, ankylosing ...
Posted by Michael Wonder on 21 Aug 2018
Paving the way for biosimilars
21 August 2018 - The FDA’s recently announced Biosimilars Action Plan will take steps to increase access for patients who ...
Posted by Michael Wonder on 02 Aug 2018
Evolus announces early resubmission to the FDA of its biologics licence application for DWP-450
2 August 2018 - Commercial launch planned for spring 2019. ...
Posted by Michael Wonder on 25 Jul 2018
Scientist invented a new pathway to approve biosimilars, and the FDA is listening
25 July 2018 - In an extraordinary move, the FDA has withdrawn the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity,” ...
Posted by Michael Wonder on 20 Jul 2018
U.S. FDA approves Pfizer's biosimilar Nivestym (filgrastim-aafi)
20 July 2018 - Nivestym, a biosimilar to Neupogen (filgrastim), is Pfizer's fourth biosimilar to be approved by the FDA. ...
Posted by Michael Wonder on 19 Jul 2018
Drug makers game the patent system and reap billions, FDA says
19 July 2018 - Gottlieb issues plan to boost biosimilar market, lower prices. ...
Posted by Michael Wonder on 18 Jul 2018
Remarks from FDA Commissioner as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan
18 July 2018 - Our ability to build a market for safe, effective biosimilar products is key for patients and ...
Posted by Michael Wonder on 17 Jul 2018
AbbVie announces Humira (adalimumab) patent license with Mylan
17 July 2018 - AbbVie announced today patent license agreements with Mylan over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 11 Jul 2018
FDA accepts biologics license application for subcutaneous formulation of Herceptin
11 July 2018 - Halozyme Therapeutics today announced that the US FDA has accepted a biologics license application from Genentech, a ...
Posted by Michael Wonder on 25 Jun 2018
As the drug industry eyes the burgeoning biosimilar market, its united front is starting to crack
25 June 2018 - The pharmaceutical industry’s massive lobbying operation has a well-earned reputation for maintaining a united front on ...
Posted by Michael Wonder on 22 Jun 2018
FDA announces program to enhance early communications with biological product developers
22 June 2018 - The FDA’s new INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting program was created ...
Posted by Michael Wonder on 21 Jun 2018
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...