Blog
RSS FeedPosted by Michael Wonder on 02 Nov 2024
Alvotech and Teva announce US FDA approval of additional presentation of Selarsdi (ustekinumab-aekn), expanding its label to include further indications approved for reference product, Stelara (ustekinumab)
22 October 2024 - Approval of Selarsdi 130 mg/26 mL in a single dose vial for intravenous infusion expands label to ...
Posted by Michael Wonder on 24 Oct 2024
Driving down the cost of biologics: lessons from a nationalised health care system
18 October 2024 - Few treatments have revolutionised care for people with chronic inflammatory disorders more than biologic and small molecule ...
Posted by Michael Wonder on 22 Oct 2024
CHMP recommends the approval of Dong-A ST’s Imuldosa, a biosimilar to Stelara
21 October 2024 - Dong-A ST announced on 18 October 2024 that its biosimilar Imuldosa (ustekinumab, development code DMB-3115), referencing ...
Posted by Michael Wonder on 18 Oct 2024
Fresenius Kabi launches Tyenne, the first and only approved tocilizumab biosimilar in Canada
17 October 2024 - Tyenne is the first and only tocilizumab biosimilar to be launched in Canada. ...
Posted by Michael Wonder on 17 Oct 2024
The science of biosimilars - updating interchangeability
18 October 2024 - Almost 15 years ago the US FDA was given the authority to approve biosimilars through the ...
Posted by Michael Wonder on 13 Oct 2024
US FDA approves Dong-A ST’s Imuldosa (ustekinumab-srlf), a biosimilar to Stelara
11 October 2024 - Dong-A ST announced on October 11 2024 that Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara, has won ...
Posted by Michael Wonder on 11 Oct 2024
EMA confirms acceptance of marketing application for AVT03, a proposed biosimilar to Prolia and Xgeva
10 October 2024 - Alvotech announced today that the EMA has accepted a marketing authorisation application for AVT03, a proposed biosimilar ...
Posted by Michael Wonder on 09 Oct 2024
Teva Prolia (denosumab) biosimilar candidate is accepted for review by US FDA and EU EMA
8 October 2024 - TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of ...
Posted by Michael Wonder on 04 Oct 2024
Blue Shield of California slashes cost of world's best selling drug
1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...
Posted by Michael Wonder on 30 Sep 2024
Fresenius Kabi and Formycon receive US FDA approval for biosimilar Otulfi (ustekinumab-aauz)
30 September 2024 - In accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has ...
Posted by Michael Wonder on 13 Sep 2024
UnitedHealth to remove AbbVie's Humira from some US drug reimbursement lists next year
10 September 2024 - UnitedHealth Group said on Tuesday it will remove AbbVie’s blockbuster rheumatoid arthritis drug Humira from some ...
Posted by Michael Wonder on 09 Sep 2024
Celltrion’s Stelara biosimilar secures UK approval
4 September 2024 - Celltrion said its Stelara (ustekinumab) biosimilar, Steqeyma, received marketing authorisation from the UK MHRA. ...
Posted by Michael Wonder on 28 Aug 2024
Cigna to remove AbbVie's Humira from some drug reimbursement lists next year
26 August 2024 - Cigna said on Monday it will remove AbbVie’s rheumatoid arthritis drug Humira from some of its ...
Posted by Michael Wonder on 26 Aug 2024
European Commission approves Celltrion’s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for the treatment of multiple chronic inflammatory diseases
25 August 2024 - The European Commission approval is based on the totality of evidence including the results from a Phase ...
Posted by Michael Wonder on 25 Aug 2024
Henlius trastuzumab receives approval in Canada
22 August 2024 - Shanghai Henlius Biotech announced that the company's business partner, Accord Healthcare has received marketing approval (Notice of ...