MB09 (denosumab biosimilar) / Insud Pharma, Amneal, Korea Kolmar - LARVOL DELTA

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