Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 24 Jul 2019
FDA approves Pfizer's biosimilar Ruxience (rituximab-pvvr), for certain cancers and auto-immune conditions
23 July 2019 - Pfizer today announced the United States FDA has approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), ...
Posted by Michael Wonder on 24 Jul 2019
Merck's biosimilar to AbbVie's Humira wins FDA approval
24 July 2019 - The U.S. FDA approved Merck & Co Inc’s biosimilar to AbbVie's blockbuster rheumatoid arthritis treatment Humira, ...
Posted by Michael Wonder on 20 Jul 2019
Amgen and Allergan's Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) now available in the United States
19 July 2019 - First biosimilar Avastin and Herceptin products to launch in the United States. ...
Posted by Michael Wonder on 11 Jul 2019
Biosimilars continue to exhibit market failure
11 July 2019 - From their inception, biosimilars in the U.S. have faced headwinds. ...
Posted by Michael Wonder on 29 Jun 2019
Pfizer receives U.S. FDA approval for its first biosimilar, Zirabev (bevacizumab-bvzr)
28 June 2019 - Pfizer today announced the U.S. FDA has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the ...
Posted by Michael Wonder on 24 Jun 2019
How big pharma suppresses ‘biosimilars’
23 June 2019 - Deals with insurers and pharmacy benefit managers at patient and taxpayer expense. ...
Posted by Michael Wonder on 14 Jun 2019
Ensuring innovation and competition for biologics leads to more timely products for patients
13 June 2019 - Today, the FDA approved the agency’s 20th biosimilar product, Kanjinti (trastuzumab-anns), for the treatment of patients with ...
Posted by Michael Wonder on 13 Jun 2019
Amgen wins FDA approval for Kanjinti injection for treatment of breast cancer, gastro-esophageal junction adenocarcinoma
13 June 2019 - U.S. FDA says Kanjinti (trastuzumab-anns) is biosimilar to Herceptin (trastuzumab). ...
Posted by Michael Wonder on 11 Jun 2019
Should the FDA disclose new filings for drugs, biologics and biosimilars?
11 June 2019 - In 2010, the FDA issued draft recommendations on increasing the transparency of the FDA’s processes and ...