Blog
RSS FeedPosted by Michael Wonder on 04 Dec 2018
The Biosimilars Forum joins calls for FDA action on biosimilar communications
3 December 2018 - The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA ...
Posted by Michael Wonder on 01 Dec 2018
AbbVie announces Humira (adalimumab) global patent license with Pfizer
30 November 2018 - AbbVie announced today patent license agreements with Pfizer over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 28 Nov 2018
FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma
28 November 2018 - The agency has now approved 15 biosimilars and is advancing new policies to improve the efficiency of ...
Posted by Michael Wonder on 14 Nov 2018
Pfizer launches epoetin alfa biosimilar, Retacrit, at 33.5% discount to reference Epogen
14 November 2018 - Pfizer announced today that it has launched its epoetin alfa biosimilar, Retacrit, at a substantial discount to ...
Posted by Michael Wonder on 09 Nov 2018
Coherus prices biosimilar to Amgen's Neulasta at 33 percent discount
9 November 2018 - Coherus BioSciences Inc said on Thursday it would price its biosimilar to Amgen Inc’s infection-fighting treatment, ...
Posted by Michael Wonder on 07 Nov 2018
AbbVie announces Humira (adalimumab) global patent license with Momenta
6 November 2018 - AbbVie announced today patent license agreements with Momenta over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 02 Nov 2018
Sandoz decides not to pursue US biosimilar rituximab; will focus on robust biosimilar portfolio for unmet access and sustainability needs
2 November 2018 - Decision follows FDA request for additional information to complement submission for biosimilar rituximab. ...
Posted by Michael Wonder on 02 Nov 2018
U.S. FDA approves Udenyca (pegfilgrastim-cbqv)
2 November 2018 - Coherus BioSciences today announced that the U.S. FDA has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved ...
Posted by Michael Wonder on 31 Oct 2018
Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz)
31 October 2018 - Biosimilar Hyrimoz (adalimumab-adaz) approved for all indications of reference medicine not protected by orphan exclusivity. ...
Posted by Michael Wonder on 19 Oct 2018
AbbVie announces global resolution of Humira (adalimumab) patent disputes with Fresenius Kabi
18 October 2018 - Agreements provide non-exclusive license to Fresenius Kabi for Humira related intellectual property in the U.S. effective 30 ...
Posted by Michael Wonder on 27 Sep 2018
Samsung Bioepis’ biologics license application for SB5 adalimumab biosimilar candidate accepted for review by the U.S. FDA
27 September 2018 - The biologics license application for SB5 was based on a 52 week Phase 3 study comparing SB5 ...
Posted by Michael Wonder on 26 Sep 2018
Mylan and Novartis to FDA: where are the suffixes?
26 September 2018 - Mylan and Novartis are taking issue with the fact that the US FDA has yet to ...
Posted by Michael Wonder on 04 Sep 2018
Biosimilar medicines are the key to success
3 September 2018 - The lives of more than 10 million Americans — those with rheumatoid arthritis, psoriatic arthritis, ankylosing ...
Posted by Michael Wonder on 21 Aug 2018
Paving the way for biosimilars
21 August 2018 - The FDA’s recently announced Biosimilars Action Plan will take steps to increase access for patients who ...
Posted by Michael Wonder on 02 Aug 2018
Evolus announces early resubmission to the FDA of its biologics licence application for DWP-450
2 August 2018 - Commercial launch planned for spring 2019. ...