Denbrayce (denosumab biosimilar) / Insud Pharma, Amneal, Korea Kolmar - LARVOL DELTA

Population PK Modeling of Denosumab Biosimilar MB09 and Reference Denosumab to Establish PK Similarity. (PubMed, Pharmaceutics) - "The mean area under the plasma concentration curve (AUC) resultant from the simulation of MB09 120 mg SC was similar to the published mean AUC observed for Xgeva 120 mg SC every four weeks. This analysis provides a valuable assessment of denosumab PK characteristics and elucidates in more detail how the MB09 PK profile compares to the denosumab RPs, supporting the totality of evidence on MB09 biosimilarity."

Journal • Osteoporosis • Rheumatology

Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA (Businesswire) - "Amneal Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia and XGEVA. mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma....The FDA has assigned a target action date in the fourth quarter of 2025....It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries."

FDA approval • FDA filing • Oncology • Osteoporosis

MB09, a denosumab biosimilar candidate: Biosimilarity demonstration in a phase I study in healthy subjects. (PubMed, Clin Transl Sci) - "Immunogenicity was low and similarly distributed. These results provide strong evidence that supports the biosimilarity between MB09 and denosumab reference products."

Clinical • Journal • P1 data

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study) (clinicaltrials.gov) - P3 | N=528 | Completed | Sponsor: mAbxience Research S.L. | Active, not recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

MB09 (denosumab biosimilar) vs reference denosumab in PMO Primary results (AACE 2024) - P3 | "PK/PD profile demonstrated similarity between treatment arms. Safety and immunogenicity profiles were similar to the RD."

Osteoporosis • Rheumatology

Complete genome sequence of Proteiniborus sp. MB09-C3, isolated from the feces of the black soldier fly larvae. (PubMed, Microbiol Resour Announc) - "MB09-C3 (= BCRC 81405), isolated from the feces of black soldier fly (Hermetia illucens) larvae. The genome of strain MB09-C3 was selected for further species delineation and comparative genomic analysis."

Journal

Amneal Adds Two Denosumab Biosimilars to U.S. Pipeline, Expanding Oncology Portfolio (Businesswire) - "Amneal Pharmaceuticals, Inc...today announced the addition of two denosumab biosimilars referencing both Prolia® and XGEVA® to its biosimilar pipeline....Under the terms of the agreement, mAbxience will fully develop the biosimilar molecule and manufacture it in its state-of-the-art, Good Manufacturing Practice (GMP)-approved facilities, while Amneal will guide the product through regulatory approval and have exclusive commercialization rights in the United States."

Licensing / partnership • Oncology

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study) (clinicaltrials.gov) - P3 | N=528 | Active, not recruiting | Sponsor: mAbxience Research S.L. | Trial completion date: Mar 2024 ➔ Jun 2024

Trial completion date • Osteoporosis • Rheumatology

A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva (clinicaltrials.gov) - P1 | N=255 | Completed | Sponsor: mAbxience Research S.L. | Active, not recruiting ➔ Completed

Trial completion

An Examination of Factors Influencing the Efficacy of Surface Disinfecting Wipes (ASM Microbe 2023) - "Testing was conducted per EPA MB-09-06: Standard Operating Procedure for Disinfectant Towelette Test, using Staphylococcus aureus and Pseudomonas aeruginosa as the challenge organisms... There are many factors to consider when developing a disinfecting wipe. The results of this study demonstrate that formulations do not perform equivalently when loaded onto different substrates. Furthermore, solution loading must be re-evaluated for each type of substrate."

Clinical

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study) (clinicaltrials.gov) - P3 | N=528 | Active, not recruiting | Sponsor: mAbxience Research S.L. | Recruiting ➔ Active, not recruiting

Enrollment closed • Osteoporosis • Rheumatology

A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva (clinicaltrials.gov) - P1 | N=255 | Active, not recruiting | Sponsor: mAbxience Research S.L. | Recruiting ➔ Active, not recruiting

Enrollment closed