Blog
RSS FeedPosted 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4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the ...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 ...
Posted by Michael Wonder on 30 May 2018
Celltrion completes resubmission for biosimilar candidate to FDA for review
30 May 2018 - U.S. FDA notified Celltrion of its re-inspection schedule regarding cGMP regular audit. ...
Posted by Michael Wonder on 23 May 2018
Rationale, opportunities, and reality of biosimilar medications
24 May 2018 - Biosimilars work like established therapeutic agents but have some dissimilarities based on differences in production. ...
Posted by Michael Wonder on 22 May 2018
Janssen questions literature review on biosimilar switching studies as authors defend it
22 May 2018 - Three employees of Johnson & Johnson’s Janssen Pharmaceuticals, which has not publicly disclosed that it is ...
Posted by Michael Wonder on 17 May 2018
U.S. FDA accepts and acknowledges Coherus BioSciences biologics license application of CHS-1701 (pegfilgrastim biosimilar candidate) for review
14 May 2018 - Coherus BioSciences today announced the U.S. FDA has accepted and acknowledged for review the re-submission of the ...
Posted by Michael Wonder on 15 May 2018
FDA approves first epoetin alfa biosimilar for the treatment of anemia
15 May 2017 - The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin ...
Posted by Michael Wonder on 10 May 2018
Games and greed delay the market entry of money-saving biosimilars
9 May 2018 - Generic medicines have saved Americans $1.67 trillion in the last decade. ...
Posted by Michael Wonder on 03 May 2018
How the U.S. compares to Europe on biosimilar approvals and products in the pipeline
2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...
Posted by Michael Wonder on 03 May 2018
Coherus Biosciences re-submits biologics license application for CHS-1701 (pegfilgrastim biosimilar candidate)
3 May 2018 - Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the re-submission of its biologics license application (BLA) for CHS-1701, ...
Posted by Michael Wonder on 02 May 2018
Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab
2 May 2018 - Sandoz, a Novartis division, announced today that the US FDA has issued a complete response letter ...