Blog
RSS FeedPosted by Michael Wonder on 25 Jul 2022
Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
Posted by Michael Wonder on 21 Jul 2022
Sandoz supplemental biologics license application accepted by US FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 July 2022 - Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study. ...
Posted by Michael Wonder on 16 Jul 2022
Polpharma Biologics announces EMA acceptance of marketing authorisation application for proposed biosimilar natalizumab
14 July 2022 - Polpharma Biologics announced today that the EMA has accepted the first-ever marketing authorisation application for biosimilar natalizumab, ...
Posted by Michael Wonder on 13 Jul 2022
Biosimilar uptake accelerates in US—and so do the savings
13 July 2022 - Amgen's early view said health care savings from the use of these biologic therapies climbed to ...
Posted by Michael Wonder on 03 Jul 2022
NHS saves 1.2 billion pounds on medicines over three years
1 July 2022 - The NHS has saved taxpayers £1.2 billion in just three years, while securing cutting-edge treatments for ...
Posted by Michael Wonder on 27 Jun 2022
FYB201, Formycon's biosimilar for Lucentis (ranibizumab), receives CHMP recommendation from EMA
24 June 2022 - Formycon and its licensing partner Bioeq announce that the CHMP of the EMA today issued a ...
Posted by Michael Wonder on 27 Jun 2022
Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, Vegzelma (CT-P16)
27 June 2022 - The positive opinion is based on the totality of evidence including the Phase III study to evaluate ...
Posted by Michael Wonder on 17 Jun 2022
Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA
17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study. ...
Posted by Michael Wonder on 06 Jun 2022
FDA approves Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab), for adults with moderate to severe rheumatoid arthritis
6 June 2022 - Now approved to treat all available Rituxan Indications. ...
Posted by Michael Wonder on 02 Jun 2022
Biogen and Samsung Bioepis’ Byooviz (ranibizumab-nuna) launches in the United States
2 June 2022 - Byooviz, priced 40% lower than Lucentis, provides an equally effective and more affordable treatment option to patients ...
Posted by Michael Wonder on 31 May 2022
Schedule of Pharmaceutical Benefits - 1 June 2022
1 June 2022 - The June 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 May 2022
Sandoz announces new global ‘Act4Biosimilars’ initiative, to improve patient access and increase adoption by at least 30% in 30+ countries by 2030
31 May 2022 - Multidisciplinary Steering Committee established to drive action includes patient advocacy leaders, healthcare professionals, biosimilar experts and industry ...
Posted by Michael Wonder on 31 May 2022
Xbrance provides update on ranibizumab biosimilar candidate FDA filing
30 May 2022 - Xbrane Biopharma has withdrawn its biologics license application for its investigational biosimilar candidate to Lucentis after ...
Posted by Michael Wonder on 30 May 2022
2022 Biosimilar Awareness Week: 30 May – 3 June
30 May 2022 - Marking a new dawn in medicine choice and affordability. ...
Posted by Michael Wonder on 28 May 2022
Amneal achieves third U.S. biosimilar approval with Fylnetra (pegfilgrastim-pbbk)
27 May 2022 - Marks Amneal’s third biosimilar approval in 2022. ...