Blog
RSS FeedPosted 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25 July 2018 - In an extraordinary move, the FDA has withdrawn the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity,” ...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 U.S. 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FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...
Posted by Michael Wonder on 18 Jun 2018
Celltrion completes resubmission to FDA for proposed trastuzumab biosimilar
18 June 2018 - Celltrion made a resubmission for the U.S. FDA approval of CT-P6, a proposed biosimilar to Herceptin ...
Posted by Michael Wonder on 13 Jun 2018
Mylan CEO promises Neulasta biosimilar will offer "significant savings" for patients
12 June 2018 - Nearly two years after taking tremendous heat for the rising cost of EpiPens, pharmaceutical giant Mylan ...
Posted by Michael Wonder on 05 Jun 2018
Embracing competition to empower biosimilars
5 June 2018 - In 2017, there were 46 new novel drug innovations, including new treatments for cancers, Parkinson’s disease, ...
Posted by Michael Wonder on 05 Jun 2018
FDA drafts new guidance on formal meetings between FDA, biosimilar sponsors
4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the ...
Posted by Michael Wonder on 04 Jun 2018
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
4 June 2018 - The U.S. FDA today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the ...
Posted by Michael Wonder on 02 Jun 2018
Amgen statement on complete response letter from the U.S. FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab)
1 June 2018 - Amgen received a complete response letter from the US FDA in response to the biologics license ...