Blog
RSS FeedPosted 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30 May 2022 - Xbrane Biopharma has withdrawn its biologics license application for its investigational biosimilar candidate to Lucentis after ...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. ...
Posted by Michael Wonder on 23 May 2022
'EMA's refusal to authorise Herceptin biosimilar unfair'
23 May 2022 - Prestige BioPharma's recent failure to get European approval for its Herceptin biosimilar could have resulted from ...
Posted by Michael Wonder on 20 May 2022
Viatris and Biocon Biologics launch Abevmy (bevacizumab), their third oncology siosimilar, in Canada
19 May 2022 - Viatris and Biocon Biologics announced today that Abevmy (bevacizumab) is now available in Canada. ...
Posted by Michael Wonder on 17 May 2022
United Kingdom MHRA grants marketing authorisation for FYB201, Formycon's biosimilar for Lucentis
17 May 2022 - Formycon and its license partner Bioeq announce that today the MHRA has granted marketing authorisation in the ...
Posted by Michael Wonder on 16 May 2022
Pfizer settles two lawsuits, starts another over etanercept biosimilar in Australia
17 May 2022 - After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit ...
Posted by Michael Wonder on 16 May 2022
Korea clears permit for Samsung Bioepis’ Lucentis biosimilar after US
16 May 2022 - Samsung Bioepis received marketing approval for Amelivu (ranibizumab), a biosimilar referencing Lucentis to treat various eye ...
Posted by Michael Wonder on 19 Apr 2022
Prioritising reference products over biosimilars led to millions of missed savings for Part D
20 April 2022 - Medicare Part D plans missed out on between $84 million and $143 million in savings by ...
Posted by Michael Wonder on 13 Apr 2022
Amneal achieves second U.S. biosimilars approval with Alymsys (bevacizumab-maly)
13 April 2022 - Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022. ...