Blog
RSS FeedPosted by Michael Wonder on 02 Dec 2019
Biosimilar trastuzumab on the PBS - information for health professionals and patients
2 December 2019 - A new biosimilar brand of trastuzumab (Kanjinti) has listed on the PBS on 1 December 2019. ...
Posted by Michael Wonder on 26 Nov 2019
Celltrion Healthcare receives EU marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis
25 November 2019 - European Union marketing approval is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety ...
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 ...
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 ...