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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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Organon & Henlius Biotech have reported availability of Bildyos (60mg/1mL) & Tuzemty (120mg/1.7mL), biosimilar versions of Prolia & Xgeva (denosumab), respectively, in Canada for all indications of reference products
Under a 2022 agreement, Henlius granted Organon exclusive global commercialization rights, excl. China, for multiple biosimilars, incl. Bildyos & Tuzemty
Denosumab is a mAb that works…
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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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The US FDA has approved sBLA for Tofidence, a biosimilar version of Actemra (tocilizumab)
Tofidence is an IL-6 receptor antagonist available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL single-dose vials for IV. The expanded approval adds indications for CAR T cell-induced severe or life-threatening cytokine release syndrome (CRS) and hospitalized adults and children (≥2 years) with COVID-19 requiring…
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Regulatory momentum stayed strong in April 2026, with key approvals including Poherdy (EC), Tuyory (EC), and multiple denosumab biosimilars in Canada, alongside NMPA IND clearances for Henlius’ HLX319 and HLX05-N and Mabwell’s Maiweijian sBLA acceptance.
Strategic activity expanded globally through Mochida–Qilu and Mabwell partnerships, while major M&A deals, Amneal–Kashiv and Sun Pharma–Organon, signaled growing biosimilar consolidation.
Pipelines and commercialization progressed with CuraTeQ’s P-III success for BP11 and Biocon’s US launch of Bosaya and Aukelso,…
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The EC has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product
Approval was based on extensive data, incl. structural & functional analytical data, PK & clinical studies, which showed similarity & interchangeability in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy &…
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Sun Pharma has entered into a definitive agreement to acquire Organon, growing Sun Pharma’s Innovative Medicines business & supporting its entry into biosimilars as a top-10 global player
As per the deal, Sun Pharma will acquire Organon for $14/share in an all‑cash transaction with an enterprise valuation of $11.75B; closing is expected in early…
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Sebela Pharmaceuticals has entered into an agreement granting Organon exclusive global rights to Miudella, a hormone-free copper intrauterine device (IUD) contraceptive
As per the deal, Sebela will receive $27.5M at closing & ~$505M in sales-based milestone payments, with tiered net sales-based double-digit royalties
Miudella was approved by the US FDA in Feb 2025, for…
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The US FDA has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product
Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed similarity & interchangeability in terms of safety, purity, & potency between Poherdy & reference pertuzumab
In 2022,…

