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RSS FeedPosted 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 ...
Posted by Michael Wonder on 18 Nov 2019
Biosimilars make progress in the Canadian market, but stakeholders see more work ahead
18 November 2019 - While much attention over the past few weeks has been on the US biosimilars market, with its ...
Posted by Michael Wonder on 18 Nov 2019
FDA approves Pfizer's biosimilar, Abrilada (adalimumab-afzb) for multiple inflammatory conditions
18 November 2019 - Pfizer today announced the United States FDA has approved Abrilada (adalimumab-afzb), as a biosimilar to Humira ...
Posted by Michael Wonder on 18 Nov 2019
Statement from Sarah Yim, acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
15 November 2019 - Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. ...
Posted by Michael Wonder on 15 Nov 2019
Valeo Pharma announces filing of a new drug submission for low molecular weight heparin in Canada
14 November 2019 - Valeo Pharma announced today that the new drug submission filed for a low molecular weight heparin ...
Posted by Michael Wonder on 14 Nov 2019
Biosimilar rituximab and insulin glargine on the PBS and other PBS Listing changes - information for health professionals and patients
14 November 2019 - Biosimilar brands of rituximab (Riximyo) and insulin glargine (Semglee) have listed on the PBS on 1 October ...
Posted by Michael Wonder on 09 Nov 2019
Teva and Celltrion announce the availability of Truxima (rituximab-abbs) injection, the first biosimilar to Rituxan (rituximab) in the United States
7 November 2019 - Truxima available week of November 11. ...
Posted by Michael Wonder on 06 Nov 2019
Is the FDA doing enough to bring biosimilars to market?
4 November 2019 - As the number of biosimilar approvals continues to rise in the US, the number of biosimilar ...
Posted by Michael Wonder on 05 Nov 2019
Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez)
5 November 2019 - Ziextenzo is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects ...
Posted by Michael Wonder on 23 Oct 2019
Adalimumab and the challenges for biosimilars
23 October 2019 - Biologic drugs are expensive therapeutic agents and represent a large and growing segment of pharmaceutical spending. ...
Posted by Michael Wonder on 16 Oct 2019
Bill to create CMS star ratings program for biosimilars introduced in House
16 October 2019 - The bipartisan bill would require HHS to evaluate Medicare Advantage (MA) plans based on whether biosimilars are ...
Posted by Michael Wonder on 10 Oct 2019
Biosimilars in the UK: where are we now and where does the NHS want to go?
9 October 2019 - The UK health service has well over a decade’s experience of dealing with biosimilars, but the ...
Posted by Michael Wonder on 07 Oct 2019
Pfenex receives U.S. FDA approval for PF708 to treat osteoporosis
7 October 2019 - Comparative human factors study report expected to be submitted to FDA as early as the second half ...
Posted by Michael Wonder on 27 Sep 2019
With Brexit looming, what does the future hold for UK biosimilars?
26 September 2019 - If and when the United Kingdom leaves the European Union, the Medicines and Healthcare Products Regulatory Agency ...
Posted by Michael Wonder on 25 Sep 2019
Paper by European regulators foresees "continuing reduction in clinical data requirements" for biosimilars
24 September 2019 - This month, Elena Wolff-Holz, chair of the EMA’s Biosimilar Medicinal Products Working Party, together with co-authors from ...