Blog
RSS FeedPosted by Michael Wonder on 14 Jan 2026
Henlius' fifth US filing product bevacizumab biosimilar HLX04 receives FDA BLA acceptance
13 January 2026 - Shanghai Henlius Biotech announced that the biologics license application for HLX04, the Company’s independently developed bevacizumab biosimilar ...
Posted by Michael Wonder on 27 Dec 2025
Amneal announces FDA approval of denosumab biosimilars referencing Prolia and Xgeva
22 December 2025 - Company expects to commercialize six biosimilars across eight presentations by 2027. ...
Posted by Michael Wonder on 05 Dec 2025
Celltrion announces US FDA approval of 300 mg strength of Omyclo (omalizumab-igec), the first and only FDA approved interchangeable biosimilar to Xolair
1 December 2025 - Celltrion today announced the US FDA has approved a new presentation of Omyclo (omalizumab-igec), the first and ...
Posted by Michael Wonder on 18 Nov 2025
Henlius and Organon announce US FDA approval of Poherdy (pertuzumab-dpzb), the first Perjeta (pertuzumab) biosimilar in the US
17 November 2025 - Shanghai Henlius Biotech and Organon today announced that the US FDA has approved the biologics license application ...
Posted by Michael Wonder on 13 Nov 2025
FDA approves new interchangeable biosimilar to Perjeta
13 November 2025 - Today, the FDA approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics) as an interchangeable biosimilar to Perjeta (pertuzumab, ...
Posted 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 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 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 05 Sep 2025
US FDA approves Henlius and Organon’s Bildyos (denosumab-nxxp) and Bilprevda (denosumab-nxxp), biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively
2 September 2025 - Shanghai Henlius Biotech and Organon today announced the US FDA has approved Bildyos (denosumab-nxxp) injection 60 mg/mL ...