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…

ByDipanshu DixitJuly 13, 2026

INSIGHTS+

Key Biosimilars Events of February 2026

Shots: Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars. Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…

ByDipanshu DixitMarch 3, 2026

NEWS

Henlius Reports the FDA IND Clearance to Initiate P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro)

Shots: The US FDA has granted IND clearance to initiate P-I trial of HLX15-SC, a biosimilar version of Darzalex Faspro (daratumumab), for the 1L treatment of multiple myeloma In Jun 2024, the P-I study of HLX15 (IV; Biosimilar, Darzalex) met its 1EP, demonstrating similar PK & comparable safety & immunogenicity to US, EU, & China-sourced…

ByRidhi RastogiFebruary 16, 2026

NEWS

Dr. Reddy’s Partners with Henlius to Commercialize HLX15 (Biosimilar, Darzalex & Darzalex Faspro) in the US & EU

Shots: Dr. Reddy’s & Henlius have entered into a license agreement to develop & market HLX15, biosimilar version of Darzalex & Darzalex Faspro (daratumumab) As per the agreement, Dr. Reddy’s will get exclusive rights to market HLX15 (SC & IV) in the US & EU in exchange for ~$131.6M ($33M upfront + milestones), plus…

ByRidhi RastogiFebruary 10, 2025

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

Key Biosimilars Events of February 2026

Henlius Reports the FDA IND Clearance to Initiate P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro)

Dr. Reddy’s Partners with Henlius to Commercialize HLX15 (Biosimilar, Darzalex & Darzalex Faspro) in the US & EU

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