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RSS FeedPosted by Michael Wonder on 09 Nov 2025
Mark Cuban Cost Plus Drug Company expands access with addition of Starjemza (ustekinumab-hmny) to give patients more power over prescription costs
6 November 2025 - New biosimilar added to portfolio reinforces the company's commitment to transparency and access ...
Posted by Michael Wonder on 07 Nov 2025
Mark Cuban is trying to shake up biosimilar pricing with a version of J&J’s best selling Stelara drug
6 November 2025 - By selling at a low price, Cuban hopes to convince health plans, employers to embrace his ...
Posted by Michael Wonder on 04 Nov 2025
US FDA grants interchangeability designation to Celltrion's denosumab biosimilars, Stoboclo (denosumab-bmwo) and Ozenvelt (denosumab-bmwo)
30 October 2025 - The US FDA approved Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable with the reference products Prolia (denosumab) ...
Posted by Michael Wonder on 30 Oct 2025
FDA moves to accelerate biosimilar development and lower drug costs
29 October 2025 - The US FDA today announced significant action to make it faster and less costly to develop ...
Posted by Michael Wonder on 24 Oct 2025
Biocon Biologics receives Health Canada spproval for Yesintek and Yesintek I.V. (ustekinumab), a biosimilar to Stelara
23 October 2025 - Biocon Biologics today announced that Health Canada has granted a notice of compliance for Yesintek (ustekinumab ...
Posted by Michael Wonder on 20 Oct 2025
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
19 October 2025 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s biologics ...
Posted by Michael Wonder on 10 Oct 2025
Celltrion receives US FDA approval for Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept)
9 October 2025 - Celltrion today announced that the US FDA has approved Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept), for the ...
Posted by Michael Wonder on 09 Oct 2025
Richter and Hikma receive FDA approval for denosumab biosimilars Enoby and Xtrenbo, referencing Prolia and Xgeva
29 September 2025 - Gedeon Richter and Hikma Pharmaceuticals announce today that the US FDA has granted approval for the ...
Posted by Michael Wonder on 07 Oct 2025
Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)
6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and ...
Posted by Michael Wonder on 07 Oct 2025
European marketing application for AVT23, a proposed biosimilar to Xolair (omalizumab), accepted by the EMA
6 October 2025 - Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT23, a proposed ...
Posted by Michael Wonder on 29 Sep 2025
EMA recommends marketing approval of Gobivaz, Alvotech’s proposed biosimilar to Simponi (golimumab) with Advanz Pharma as commercialisation partner
22 September 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP has adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 23 Sep 2025
EMA recommends marketing authorisation of AVT03, Alvotech’s proposed biosimilar to Prolia and Xgeva
22 September 2025 - Alvotech today announced that the EMA's CHMP has adopted a positive opinion recommending approval for AVT03, Alvotech’s ...
Posted by Michael Wonder on 20 Sep 2025
Health Canada approves Celltrion’s Stoboclo and Osenvelt (CT-P41), denosumab biosimilars for the treatment of all indications approved for the reference products, Prolia and Xgeva, respectively
18 September 2025 - The approval is based on the totality of evidence including results from a Phase III clinical ...
Posted by Michael Wonder on 19 Sep 2025
Biocon Biologics receives US FDA approval for Bosaya and Aukelso, denosumab biosimilars
17 September 2025 - Biocon Biologics today announced that the US FDA has approved Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous ...
Posted by Michael Wonder on 19 Sep 2025
Biocon Biologics' Yesafili (aflibercept) now publicly funded in Ontario, Canada for the advanced treatment of patients with retinal diseases
18 September 2025 - -- Biocon Biologics is pleased to announce that Yesafili (aflibercept), a biosimilar to Eylea (aflibercept) injection, ...