Blog
RSS FeedPosted by Michael Wonder on 20 Mar 2019
Biosimilar groups offer proposals to help US better mirror EU successes
19 March 2019 - With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups ...
Posted by Michael Wonder on 20 Mar 2019
Biosimilar approval and adoption in the U.S. needs to be expedited
20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...
Posted by Michael Wonder on 19 Mar 2019
Biosimilars Forum and Medicines for Europe call for changes to the US biosimilars market
19 March 2019 - The Biosimilars Forum and Medicines for Europe today released a joint white paper that discusses how Europe ...
Posted by Michael Wonder on 07 Mar 2019
Statement from FDA Commissioner on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products
7 March 2019 - We’re at a critical point for the future of biosimilars in the U.S. Millions of American ...
Posted by Michael Wonder on 07 Feb 2019
What is a biosimilar, exactly?
5 February 2019 - They’re meant to save money for the health care system, carve into pharma’s profits, and finally ...
Posted by Michael Wonder on 19 Jan 2019
Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod
19 January 2019 - The U.S. FDA said on Friday it had approved a biosimilar to Roche’s blockbuster breast cancer ...
Posted by Michael Wonder on 15 Jan 2019
How a 'regulatory dead zone' may be holding up copycat insulin
14 January 2019 - The insulin market has increasingly attracted scrutiny from politicians, regulators and patient groups, as prices ramp ...
Posted 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. ...