Blog
RSS FeedPosted by Michael Wonder on 23 Nov 2021
The BBB’s threat to biosimilar drug development
23 November 2021 - In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that ...
Posted by Michael Wonder on 16 Nov 2021
Viatris and Biocon Biologics announce launch of interchangeable Semglee (insulin glargine-yfgn) injection and insulin glargine (insulin glargine-yfgn) injection
16 November 2021 - Branded and unbranded versions of the first-ever interchangeable biosimilar in the U.S. provide more affordable options for ...
Posted by Michael Wonder on 11 Nov 2021
FDA touts success and challenges in biosimilar development
10 November 2021 - A top official from the US FDA offered a mixed assessment of the agency’s biosimilars program, noting ...
Posted by Michael Wonder on 09 Nov 2021
FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics
9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress ...
Posted by Michael Wonder on 18 Oct 2021
FDA approves Cyltezo, the first interchangeable biosimilar to Humira
18 October 2021 - The U.S. FDA approved the first interchangeable biosimilar product to treat certain inflammatory diseases. ...
Posted by Michael Wonder on 05 Oct 2021
FDA’s naming rule for biosimilars has undermined Congress and health care
4 October 2021 - I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of my ...
Posted by Michael Wonder on 02 Oct 2021
Formycon and Bioeq announce file acceptance for FYB201, a biosimilar candidate to Lucentis (ranibizumab) by the U.S. FDA
1 October 2021 - Formycon and its license partner Bioeq announce that the U.S. FDA accepted the biologics license application for ...
Posted by Michael Wonder on 26 Sep 2021
FDA tweaks biosimilar application review program
25 September 2021 - The FDA has struggled during the COVID-19 pandemic to conduct timely reviews of biosimilar approval applications. ...
Posted by Michael Wonder on 20 Sep 2021
Alvotech provides update on FDA action regarding AVT02, proposed high concentration biosimilar to Humira (adalimumab)
20 September 2021 - Alvotech today announced that the FDA is deferring action on the application for AVT02, the company’s proposed ...
Posted by Michael Wonder on 20 Sep 2021
FDA approves first biosimilar to treat macular degeneration disease and other eye conditions
17 September 2021 - The U.S. FDA today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the ...
Posted by Michael Wonder on 09 Aug 2021
Ophthalmologist group wants U.S. Government to push back against Avastin biosimilars
10 August 2021 - The American Academy of Ophthalmology says biosimilar alternatives to Avastin have never been tested in the ...
Posted by Michael Wonder on 06 Aug 2021
Formycon and Bioeq announce submission of the biologics license application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the U.S. FDA
5 August 2021 - Formycon and its license partner Bioeq announce that the biologics license application for FYB201, Formycon’s biosimilar ...
Posted by Michael Wonder on 28 Jul 2021
FDA approves first interchangeable biosimilar insulin product for treatment of diabetes
28 July 2021 - Availability of insulin products will help increase access and potentially lower the cost of insulin for people ...
Posted by Michael Wonder on 27 Jul 2021
J&J and Pfizer quietly resolve Remicade biosimilar lawsuit
27 July 2021 - In 2017, Pfizer filed a lawsuit against J&J alleging that the company undertook anticompetitive practices in a ...
Posted by Michael Wonder on 20 Jun 2021
US plays catch-up with Europe over biosimilar patents
17 June 2021 - Moves to ease market access for generic drug makers are gaining momentum. ...