Blog
RSS FeedPosted 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 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 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 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
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 ...
Posted by Michael Wonder on 09 Feb 2020
Biosimilars and interchangeable biosimilars: licensure for fewer than all conditions of use for which the reference product has been licensed guidance for industry
5 February 2020 - This guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service Act ...
Posted by Michael Wonder on 03 Feb 2020
FDA and FTC announce new efforts to further deter anti-competitive business practices, support competitive market for biological products to help Americans
3 February 2020 - The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding ...
Posted by Michael Wonder on 21 Jan 2020
The biosimilar solution to expensive cancer care
20 January 2020 - In a recent column in Evidence-Based Oncology, Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer ...
Posted by Michael Wonder on 20 Dec 2019
Amgen and Allergan submit biologics license application for ABP 798, biosimilar candidate to Rituxan (rituximab), to U.S. FDA
19 December 2019 - Filing for ABP 798 supported by two comparative clinical studies. ...
Posted by Michael Wonder on 18 Dec 2019
Statement from Anna Abram, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on low-cost biosimilar and interchangeable protein products
17 December 2019 - Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is ...
Posted by Michael Wonder on 11 Dec 2019
Biosimilar stakeholders praise removal of biologic exclusivity provisions from USMCA
11 December 2019 - An agreement on the United States–Mexico–Canada Agreement, a trade deal that updates the North American Free ...
Posted by Michael Wonder on 06 Dec 2019
FDA approves Amgen's Avsola (infliximab-axxq), for the same indications as Remicade (infliximab)
6 December 2019 - Amgen's fourth FDA approval from biosimilars portfolio. ...
Posted by Michael Wonder on 25 Nov 2019
Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
25 November 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes. ...
Posted by Michael Wonder on 19 Nov 2019
FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate
19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...