Blog
RSS FeedPosted by Michael Wonder on 22 Dec 2024
Dong-A ST secures European approval for Stelara biosimilar Imuldosa
19 December 2024 - Global market expansion accelerates with back to back FDA and EC authorisations. ...
Posted by Michael Wonder on 18 Dec 2024
US FDA approves Celltrion's Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab)
17 December 2024 - Steqeyma is expected to be marketed in the US in February 2025. ...
Posted by Michael Wonder on 16 Dec 2024
EMA’s CHMP recommends approval of Biocon Biologics’ Yesintek, biosimilar to J&J’s Stelara
15 December 2024 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of Yesintek, ...
Posted by Michael Wonder on 13 Dec 2024
Hikma and Richter announce FDA submission acceptance for denosumab biosimilar products
12 December 2024 - Gedeon Richter and Hikma Pharmaceuticals today announced that the US FDA had accepted for review the ...
Posted by Michael Wonder on 11 Dec 2024
Health Canada approves Celltrion’s Omlyclo (CT-P39), the first and only omalizumab biosimilar in Canada
9 December 2024 - Omlyclo (CT-P39) is the first and only omalizumab biosimilar referencing Xolair approved in Canada to treat multiple ...
Posted by Michael Wonder on 10 Dec 2024
PHARMAC seeks feedback to fund medicines for liver and ovarian cancer
9 December 2024 - PHARMAC is consulting on a proposal to fund bevacizumab (branded as Vegzelma) as a cancer medicine ...
Posted by Michael Wonder on 07 Dec 2024
US FDA approves Biocon Biologics' Yesintek biosimilar to J&J's Stelara (ustekinumab)
2 December 2024 - Biocon Biologics announced today that the US FDA has approved Yesintek (ustekinumab-kfce), a biosimilar to the ...
Posted by Michael Wonder on 15 Nov 2024
Sandoz receives European Commission approval for Afqlir (aflibercept), further strengthening leading biosimilar portfolio
15 November 2024 - Afqlir (aflibercept) approved to treat various retinal diseases, including neovascular age-related macular degeneration. ...
Posted by Michael Wonder on 05 Nov 2024
European Medicines Agency confirms acceptance of marketing authorisation application for AVT05, a proposed biosimilar to Simponi (golimumab)
4 November 2024 - Alvotech and Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT05, ...
Posted 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 ...