Blog
RSS FeedPosted by Michael Wonder on 14 Jan 2019
Samsung faces resistance from big pharma in the U.S.
11 January 2019 - Incumbent biologic drug makers use rebates and exclusive contracts to fend off competition from new entrants. ...
Posted by Michael Wonder on 17 Dec 2018
Amgen submits biologics license application for ABP 710 (biosimilar infliximab) to US Food And Drug Administration
17 December 2018 - Filing for ABP 710, a biosimilar candidate to infliximab, supported by Phase 3 study in patients with ...
Posted by Michael Wonder on 15 Dec 2018
Celltrion and Teva announce FDA approval of Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, for the treatment of HER2-over-expressing breast cancer for certain indications
15 December 2018 - Celltrion and Teva Pharmaceutical Industries today announced that the U.S. FDA has approved Herzuma (trastuzumab-pkrb), a ...
Posted by Michael Wonder on 12 Dec 2018
FDA takes aim at pharma’s biosimilar-delaying tactics
12 December 2018 - Ever-rising cost of insulins also to be targeted. ...
Posted by Michael Wonder on 11 Dec 2018
Statement from FDA Commissioner on new actions advancing the agency’s biosimilars policy framework
11 December 2018 - Our public health obligations touch on many aspects of how medical products are developed and used ...
Posted by Michael Wonder on 10 Dec 2018
Pfenex submits new drug application to U.S. FDA seeking approval of PF708 for the treatment of osteoporosis
10 December 2018 - Submitted as a 505(b)(2) NDA with an expected ten month review. ...
Posted 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. ...