Blog
RSS FeedPosted by Michael Wonder on 03 Apr 2020
COVID-19 and the supply and distribution of generic and biosimilar prescription medicines in Canada
1 April 2020 - The following is a statement from Jim Keon, President of the Canadian Generic Pharmaceutical Association (CGPA) ...
Posted by Michael Wonder on 02 Apr 2020
Biosimilars could disappear if the Supreme Court overturns the ACA
1 April 2020 - With the sense of urgency rightly focused on slowing or stopping the spread of COVID-19, it ...
Posted by Michael Wonder on 02 Apr 2020
Pfizer receives European approval for oncology biosimilar Ruxience (rituximab)
2 April 2020 - Pfizer today announced that the European Commission has approved Ruxience (rituximab), a monoclonal antibody and biosimilar to ...
Posted by Michael Wonder on 30 Mar 2020
Mylan and Lupin announce positive CHMP opinion for Nepexto, biosimilar etanercept
27 March 2020 - Mylan and Lupin today announced that the EMA's CHMP has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 24 Mar 2020
Samsung Bioepis announces FDA approval of 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb)
24 March 2020 - 150 mg and 420 mg vial of Ontruzant are now approved. ...
Posted by Michael Wonder on 24 Mar 2020
Biosimilar pegfilgrastim on the PBS - information for health professionals and patients
24 March 2020 - The first biosimilar brand of pegfilgrastim (Ziextenzo) has listed on the PBS on 1 March 2020. ...
Posted by Michael Wonder on 17 Mar 2020
Teva and Celltrion Healthcare announce U.S. availability of Herzuma (trastuzumab-pkrb) for injection
16 March 2020 - Teva Pharmaceuticals USA and Celltrion Healthcare today announced that Herzuma (trastuzumab-pkrb) for Injection, a biosimilar to Herceptin, ...
Posted by Michael Wonder on 12 Mar 2020
HHS Secretary Alex Azar expresses hope in biosimilar uptake, notes positive momentum
11 March 2020 - HHS Secretary Alex Azar discussed the future of biosimilars in the United States and the actions taken ...
Posted by Michael Wonder on 09 Mar 2020
PhRMA: federal biosimilar payment policies are having a positive effect
4 March 2020 - Katie Verb, director of policy and research for the biopharmaceutical industry group PhRMA, discusses recent policy changes ...
Posted by Michael Wonder on 09 Mar 2020
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar bevacizumab for review
9 March 2020 - Biocon and Mylan today announced that the U.S. FDA has accepted Mylan’s biologics license application for ...
Posted by Michael Wonder on 09 Mar 2020
Celltrion applies for European approval of Humira biosimilar
9 March 2020 - Celltrion said Monday that it applied for the European Medicine Agency’s commercialization approval of CT-P17, a ...
Posted by Michael Wonder on 08 Mar 2020
Five years on, biosimilars need support from all health care players
6 March 2020 - Today marks a milestone for the U.S. biosimilar market: the FDA approved our first biosimilar, Sandoz’s ...
Posted by Michael Wonder on 24 Feb 2020
Alberta’s switch to biosimilar drugs may pose legal challenges for doctors
24 February 2020 - Prescribing cheaper medications for arthritis, diabetes or Crohn’s disease could be at odds with physicians’ legal requirement ...
Posted by Michael Wonder on 24 Feb 2020
FDA launches new Purple Book searchable database to help patients and prescribers identify FDA-approved biologic and biosimilar treatment options
24 February 2020 - Today, the FDA is releasing the first phase of the enhancement of the “Purple Book: Database of ...
Posted by Michael Wonder on 19 Feb 2020
Understanding the role of comparative clinical studies in the development of oncology biosimilars
14 February 2020 - Biosimilars have the potential to broaden patient access to biologics and provide cost savings for health care ...