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Henlius & Organon
NEWS

Organon and Henlius Launch Bildyos and Tuzemty (Biosimilars, Prolia and Xgeva) in Canada

Shots: 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…
June 23, 2026

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Samsung Bioepis and Organon
NEWS

Samsung Bioepis & Organon Expand Deal to Commercialize Pyzchiva (Biosimilar, Stelara) in Canada

Shots: 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…
June 18, 2026

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INSIGHTS+

Key Biosimilars Events of April 2026 

Shots:  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,…
May 5, 2026

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Henlius & Organon
NEWS

Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)

Shots: 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 &…
April 30, 2026

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NEWS

Sun Pharma to Acquire Organon for ~$11.75B

Shots: 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…
April 27, 2026

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Henlius & Organon
NEWS

Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)

Shots: 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,…
November 19, 2025

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Henlius & Organon
NEWS

Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022, Henlius…
September 22, 2025

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Henlius & Organon
NEWS

Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable quality, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022,…
September 3, 2025

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