Blog
RSS FeedPosted by Michael Wonder on 21 Jul 2021
Sorrento announces its partner Mabpharm has received marketing approval in China for infliximab biobetter
20 July 2021 - Sorrento to exclusively market the product outside of China including US, Japan and Europe. ...
Posted by Michael Wonder on 02 Jul 2021
Formycon and Bioeq announce submission of the marketing authorisation application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the EMA
29 June 2021 - Formycon and its license partner Bioeq AG announce that the marketing authorisation application for FYB201, Formycon’s ...
Posted by Michael Wonder on 02 Jul 2021
Bevacizumab on the PBS
2 July 2021 - Mvasi, a biosimilar brand of bevacizumab, was listed on the PBS from 1 June 2021, as ...
Posted by Michael Wonder on 27 Jun 2021
Samsung Bioepis and Biogen receive positive CHMP opinion for ranibizumab biosimilar, Byooviz
25 June 2021 - Samsung Bioepis and Biogen today announced that the EMA's CHMP has adopted a positive opinion for Byooviz, ...
Posted by Michael Wonder on 20 Jun 2021
US plays catch-up with Europe over biosimilar patents
17 June 2021 - Moves to ease market access for generic drug makers are gaining momentum. ...
Posted by Michael Wonder on 17 Jun 2021
Amneal announces U.S. FDA filing acceptance of biologics license application for bevacizumab
17 June 2021 - Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. ...
Posted by Michael Wonder on 02 Jun 2021
Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application
2 June 2021 - Lupin today announced that the U.S. FDA has accepted the biologics license application for its proposed ...
Posted by Michael Wonder on 02 Jun 2021
Experts expect to see “second wave” of biosimilars approvals
2 June 2021 - Experts expect to see a second wave of biosimilar approvals, though continued Medicare Part D reimbursement challenges ...
Posted by Michael Wonder on 21 May 2021
Biosimilar bevacizumab on the PBS - information for health professionals and patients
21 May 2021 - A biosimilar brand of bevacizumab (Mvasi) will be listed on the PBS on 1 June 2021. Information ...
Posted by Michael Wonder on 18 May 2021
Quebec announces intention to implement a biosimilar switching policy
18 May 2021 - Biosimilars Canada today congratulated the Government of Quebec and Minister of Health and Social Services Christian ...
Posted by Michael Wonder on 18 May 2021
Sandoz Canada congratulates the Quebec government on implementing a shift towards biosimilars
18 May 2021 - The shift announced by Quebec will follow a similar approach to policies introduced in British Columbia, Alberta ...
Posted by Michael Wonder on 17 May 2021
Sandoz Canada launches its 6th biosimilar with Inclunox and Inclunox HP (enoxaparin sodium solution for injection 100 mg/mL and 150 mg/mL (high potency))
17 May 2021 - New Sandoz biosimilar launch can potentially lower healthcare costs, especially for Canadian hospitals, as 75% of the ...
Posted by Michael Wonder on 17 May 2021
US Supreme Court denies Sandoz petition to review biosimilar Erelzi (etanercept-szzs) case
17 May 2021 - Decision not to review Federal Circuit July 2020 ruling continues to prevent Sandoz launch of more affordable ...
Posted by Michael Wonder on 11 May 2021
US, EU regulators discuss tailoring biosimilar approvals
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
Posted by Michael Wonder on 06 May 2021
Alberta, Canada, begins mandating switches from originator to biosimilar Humira
6 May 2021 - Alberta, Canada becomes the latest province to begin switching patients from originator adalimumab (Humira) to biosimilar ...