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Accord BioPharma Reports Commercial Availability of Osvyrti and Jubereq (Biosimilars, Prolia & Xgeva) in the US

Shots: Accord BioPharma has reported the launch of Osvyrti & Jubereq, interchangeable biosimilars to Amgen’s Prolia & Xgeva (denosumab), in the US Osvyrti (60mg PFS) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer…
July 24, 2026

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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.…
July 21, 2026

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Samsung Bioepis and Organon
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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…
July 20, 2026

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Henlius Reports First Patient Dosing in P-I Trial of HLX18 (Biosimilar, Opdivo) in China 

Shots:  Henlius has dosed the first patient in China in the P-I (HLX18-MRST001) trial assessing its nivolumab biosimilar, HLX18, in patients with resected solid tumors  The study will compare HLX18 vs. Opdivo in patients with resected solid tumors, evaluating PK similarity, efficacy, safety, and immunogenicity following monotherapy  HLX18 is Henlius' nivolumab biosimilar candidate, developed under global biosimilar guidelines. Reference nivolumab is approved worldwide for multiple cancers, including melanoma, NSCLC, RCC, HCC, urothelial, gastric, esophageal, colorectal, and head & neck cancers  Ref: Henlius  |  Image: Henlius   | Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more…
July 16, 2026

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Formycon Partners with OneSource Specialty Pharma for Biosimilars 

Shots:  Formycon and OneSource Specialty Pharma have entered into a strategic manufacturing partnership for biosimilars  As per the deal, OneSource will act as Formycon’s strategic manufacturing partner, providing integrated Drug Substance (DS) and Drug Product (DP) manufacturing from its advanced biologics facility in Bangalore, India  The collaboration combines Formycon’s biosimilar development expertise with OneSource’s end-to-end biologics manufacturing capabilities to advance Formycon’s global biosimilar programs  Ref: Formycon |  Image:…
July 14, 2026

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Henlius Reports First Patient Dosing in P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro) in the US 

    Shots:  Henlius has dosed the first U.S. patient in the global P-I HLX15-SC (HLX15-SC-NDMM-001) trial, a biosimilar version of Darzalex Faspro, as a 1L treatment for newly diagnosed multiple myeloma (NDMM)  The study will compare HLX15-SC vs. US-licensed Darzalex Faspro in transplant-ineligible NDMM patients, evaluating PK similarity, safety, tolerability, immunogenicity, and efficacy in combination with lenalidomide & dexamethasone (Rd)  HLX15 is an anti-CD38 daratumumab biosimilar candidate for…
July 13, 2026

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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,…
July 10, 2026

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Samsung Bioepis Partners with Teva  to Commercialize Opuviz  (Biosimilar, Eylea) in Canada 

 Shots:  Samsung Bioepis & Teva have entered into a license and commercialization agreement to commercialize Opuviz (Biosimilar, Eylea) in Canada  As per the deal, Samsung Bioepis will be responsible for the registration & manufacture of the products, while Teva Canada will hold commercialization rights  Opuviz was approved by Health Canada in October 2025 for wet AMD, CRVO/BRVO-related macular edema, DME, and mCNV. Samsung Bioepis' aflibercept biosimilar is also marketed in EU and South…
July 9, 2026

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Henlius Reports First Patient Dosing in P-I Trial of HLX05-N (Biosimilar, Erbitux) in China 

Shots:  Henlius has dosed the first patient in China in the P-I HLX05-N (HLX05-N-mCRC102), a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)  The study will compare HLX05-N vs. US & EU sourced Erbitux in mCRC, evaluating PK similarity, efficacy, safety, and immunogenicity in combination with mFOLFOX6 CT  HLX05-N is Henlius' cetuximab biosimilar candidate, developed under global biosimilar guidelines, with analytical and non-clinical studies demonstrating high…
July 8, 2026

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