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The MHLW has granted marketing approval to Ustekinumab BS IV infusion 130mg 「NIPRO」, a biosimilar version of Stelara (ustekinumab), for induction therapy in mod. to sev. active Crohn’s disease when other treatments are ineffective
Additionally, the MHLW approved Ustekinumab BS SC Injection 45mg Syringes 「NIPRO」in Dec 2025, which was then launched in May 2026
The biosimilar…
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Samsung Bioepis has reported the commercial launch of Opuviz 40 mg/mL solution (PFS), a biosimilar version of Eylea (aflibercept) across the EU
Opuviz (aflibercept) is a VEGF inhibitor that blocks abnormal blood vessel growth and leakage in the eye. Samsung Bioepis launched the 40 mg/mL vial in May’26. The PFS formulation received a positive CHMP opinion in Nov’25 for the same indications
Opuviz 40…
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Samsung Bioepis & Harrow have reported interim data from a P-IV post-marketing surveillance study on SB11, a biosimilar version of Lucentis (ranibizumab), conducted in South Korea from May 2022 to May 2026
The interim analysis incl. 298 of 305 enrolled pts (182 treatment-naïve & 116 switched), with investigator-determined dosing intervals & follow-up through 24wks.…
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Organon & Samsung Bioepis have expanded their development and commercialisation agreement to commercialise a new biosimilar in Australia
As per the deal, Organon will receive exclusive commercial rights to the biosimilar in Australia while Samsung Bioepis will be responsible for full development, manufacturing & regulatory responsibilities
The amended agreement expands their collaboration to 4…
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June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC), and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology, ophthalmology, oncology, osteoporosis, and reproductive medicine.
Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.
Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.
Celltrion Seeks…
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Samsung Bioepis, in partnership with Harrow, has relaunched Byooviz, a biosimilar to Lucentis (ranibizumab), in the US
Byooviz was initially commercialized by Biogen beginning in Jun 2022, before Biogen returned the US commercial rights to Samsung Bioepis at the end of 2025
Approved by the FDA in 2021 as the first ophthalmology biosimilar, Byooviz…
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Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026
The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT,…
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Samsung Bioepis & Organon have expanded their development & commercialization agreement for Pyzchiva, a biosimilar version of Stelara (ustekinumab), with launch expected in 2026
As per the deal, Organon will gain exclusive commercialization rights to Pyzchiva in Canada, while Samsung Bioepis retains responsibility for development, manufacturing, & regulatory activities.
The addition of Pyzchiva expands the…
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May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.
Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.
Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…
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Samsung Bioepis to directly commercialize Opuviz 40 mg/mL solution for injection in a vial, a biosimilar version of Eylea (aflibercept), across the EU
Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and…

