Articles from Kashiv BioSciences, LLC

Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that Health Canada has granted marketing authorization for its Pegfilgrastim Injection, enabling its commercial launch in this market. This marks an important step in Kashiv’s strategy to expand access to high-quality biosimilars in global markets.

Kashiv Biosciences, LLC, a global leader in biopharmaceutical innovation, today announced that their abatacept biosimilar candidate, KSHB002, has successfully met the primary endpoints in its Phase 1 clinical trial. The trial demonstrated pharmacokinetic equivalence to the US-licensed and EU-authorized reference product, ORENCIA®.

Kashiv BioSciences, LLC, a global vertically integrated biopharmaceutical company, announced the appointment of Mandar Borkar as Global Chief Financial Officer (CFO) and Ross Oehler as Global Chief Legal Officer (CLO).

Kashiv BioSciences, LLC, a global vertically integrated biopharmaceutical company, is pleased to announce the appointment of Dr. Sandeep Nilkanth Athalye as Global Chief Executive Officer. Dr. Athalye, a seasoned leader with over two decades of experience in strategic and operational roles within the global pharmaceutical industry, will oversee company operations and drive strategic growth across key markets, including the United States, Europe, and Asia. Dr. Athalye’s previous leadership roles span Biocon Biologics, Boehringer Ingelheim, Novartis, and Schering-Plough Research Institute.

Kashiv BioSciences, LLC today announced the completion of patient enrollment for its Phase III clinical trial of ADL018, a biosimilar candidate to XOLAIR®. This pivotal study aims to compare the efficacy, safety, tolerability, and immunogenicity of ADL018 with XOLAIR® in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic despite taking H1 antagonists. This clinical trial enrolled total 600 patients across multiple sites globally (NCT05774639). The Phase 1 PK/PD study in healthy volunteers was successfully concluded in June 2023 (NCT05413161).

Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has entered into an exclusive licensing agreement for ADL018, a proposed biosimilar to omalizumab referencing XOLAIR®, with Amneal Pharmaceuticals, Inc. (“Amneal”) for the United States.

Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has enrolled the first patient in its Phase III clinical study involving ADL018, the Company’s biosimilar candidate to XOLAIR®. The objective of the study is to compare ADL018 and XOLAIR® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic on H1 antihistamine treatment. The study is expected to enroll 600 patients globally in sites across the United States, Europe, and India (NCT05774639).

Kashiv Biosciences, LLC (“Kashiv” or the “Company”) today announced that ADL018, a biosimilar candidate to Xolair® (omalizumab), completed a successful global Phase 1 clinical study in healthy volunteers.

Kashiv Biosciences, LLC (“Kashiv” or the “Company”) is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has approved its Biologics License Application (“BLA”) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta®. The product will be marketed under the proprietary name FYLNETRA®.