Samsung Bioepis and Harrow Present Interim P-IV PMS Study Data on SB11 (Biosimilar, Lucentis) at ASRS 2026

Shots: 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.…

ByRidhi Rastogi2 days ago

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Organon and Samsung Bioepis Expand Commercialisation Agreement to Broaden Biosimilar Access in Australia

Shots: 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…

ByRidhi Rastogi2 days ago

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Polpharma and Teva Sign Exclusive Licensing Deal for a Biosimilar Candidate to Ocrevus

Shots: Polpharma has granted Teva exclusive rights to commercialize both IV & SC formulations of Polpharma’s proposed biosimilar to Ocrevus (ocrelizumab) for multiple sclerosis, upon regulatory approval As per the deal, Polpharma will lead biosimilar development & manufacturing, while Teva will oversee regulatory filings & commercialization across the US, EU, Brazil, Canada, Australia, New Zealand,…

ByRidhi RastogiJuly 10, 2026

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The US FDA Approves Accord BioPharma’s Ennumo (Biosimilar, Neulasta)

Shots: The US FDA has approved Ennumo, a biosimilar to Neulasta (pegfilgrastim), expanding Accord’s biosimilar portfolio & supporting its goal to launch 20 biosimilars in the US by 2030 Ennumo is approved for adults & pediatric pts (newborn & older) to reduce incidence of infection in febrile neutropenia in non-myeloid malignancies receiving myelosuppressive anti-cancer drugs…

ByRidhi RastogiJuly 10, 2026

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Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US

Shots: 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…

ByRidhi RastogiJuly 1, 2026

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Orion Pharma Partners with Shilpa Medicare to Commercialize Nivolumab Biosimilar in the EU

Shots: Orion Pharma has entered into an agreement with Shilpa Biologicals to commercialize IV nivolumab biosimilar that is currently under development, across Europe As per the deal, Orion will gain exclusive right to distribute, market & sell the biosimilar in the EU, while Shilpa will supply the product & receive certain development & regulatory milestone…

ByRidhi RastogiJune 30, 2026

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Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

Shots: 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,…

ByRidhi RastogiJune 29, 2026

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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…

ByRidhi RastogiJune 23, 2026

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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…

ByRidhi RastogiJune 18, 2026

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CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx)

Shots: The Chinese NMPA has accepted the marketing application for its secukinumab injection, a biosimilar version of Cosentyx, submitted as a Class 3.3 therapeutic biologic The marketing authorization application is supported by a P-I PK similarity study in healthy volunteers and a P-III equivalence study in psoriasis pts, demonstrating that the product is highly similar to Cosentyx in efficacy, safety, PK, and immunogenicity. Detailed results will be…

ByDipanshu DixitJune 18, 2026

Samsung Bioepis and Harrow Present Interim P-IV PMS Study Data on SB11 (Biosimilar, Lucentis) at ASRS 2026

Organon and Samsung Bioepis Expand Commercialisation Agreement to Broaden Biosimilar Access in Australia

Polpharma and Teva Sign Exclusive Licensing Deal for a Biosimilar Candidate to Ocrevus

The US FDA Approves Accord BioPharma’s Ennumo (Biosimilar, Neulasta)

Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US

Orion Pharma Partners with Shilpa Medicare to Commercialize Nivolumab Biosimilar in the EU

Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

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

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

CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx)

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