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…

ByRidhi RastogiSeptember 22, 2025

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,…

ByRidhi RastogiSeptember 3, 2025

NEWS

Henlius Receives the CHMP’s Positive Opinion for HLX14 (Biosimilar, Prolia/Xgeva)

Shots: Shots: The CHMP has recommended approval of HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab) for all indications of the reference product; review is ongoing in the US, Canada & other regions Opinion was based on multiple H2H trials, incl. analytical & clinical studies, which showed similar quality, efficacy & safety of HLX14 vs…

ByRidhi RastogiJuly 29, 2025

NEWS

HanchorBio Out-Licenses HCB101 to Shanghai Henlius Biotech For ~$202M

Shots: HanchorBio entered into an out-licensing agreement with Shanghai Henlius Biotech and granted exclusive rights to develop and commercialize HCB101 in Greater China, Southeast Asia, and MENA Under the terms and agreement, HanchorBio will receive $10M upfront and up to $192M in development and regulatory milestones, plus tiered royalties Henlius will also oversee development, production,…

ByPrince GiriJuly 1, 2025

INSIGHTS+

Key Biosimilars Events of April 2025

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   Henlius Collaborates with Sandoz for the Commercialization of HLX13. Our team at PharmaShots…

ByDipanshu DixitMay 6, 2025

NEWS

Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy)

Shots: Henlius has granted Sandoz exclusive rights of the HLX13, a biosimilar version of Yervoy (ipilimumab), which is being assessed in a Henlius-led P-I/III trial for inoperable HCC, targeting enrollment of 656 pts As per the deal, Sandoz will register & market HLX13 in Australia, Canada, EU, Japan, & the US in exchange for milestone-based…

ByRidhi RastogiApril 30, 2025

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

NEWS

Accord Healthcare (Intas) Receives EC Approval for Hetronifly (Serplulimab) as 1L Treatment of ES-SCLC

Shots: The EC has approved Hetronifly + CT (carboplatin & etoposide) as a 1L treatment for extensive-stage small cell lung cancer (ES-SCLC) pts. Serplulimab, an anti-PD-1 mAb for 1L SCLC therapy, is approved in China and several SEA countries. ESMO rates it 4/5 on the MCBS for ES-SCLC. Its trial results were published in…

ByRidhi RastogiFebruary 6, 2025

NEWS

Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC

Shots: The positive opinion of Hetronifly (anti-PD-1 mAb) was supported by ASTRUM-005 study assessing it with CT vs PBO as a 1L treatment of ES-SCLC patients (n=585) in various regions. It is approved in China under the brand name Hansizhuang for the same Henlius partnered with Intas in 2023 to develop & commercialize…

ByDipanshu DixitSeptember 21, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in March 2023

Shots: The EMA approved 4 New Chemical Entity (NCE) and 5 Biologic Drugs in March 2023, leading to treatments for patients and advances in the healthcare industry In March 2023, the major highlights drugs were Reblozyl’s Approval for anemia in adult patients with non-transfusion-dependent beta thalassemia, Pombiliti for late-onset pompe disease PharmaShots has compiled a…

BySenior EditorApril 27, 2023

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

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

Henlius Receives the CHMP’s Positive Opinion for HLX14 (Biosimilar, Prolia/Xgeva)

HanchorBio Out-Licenses HCB101 to Shanghai Henlius Biotech For ~$202M

Key Biosimilars Events of April 2025

Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy)

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

Accord Healthcare (Intas) Receives EC Approval for Hetronifly (Serplulimab) as 1L Treatment of ES-SCLC

Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC

Insights+: EMA Marketing Authorization of New Drugs in March 2023

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