Home

UK Medicines and Healthcare Products Regulatory Agency has Validated and Accepted the Marketing Authorization Application for ADL-018, a Proposed Biosimilar of Xolair® (omalizumab)

Published 6 days ago via Business Wire

Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application (MAA) for ADL-018, the Company’s proposed biosimilar for Xolair® (omalizumab). The acceptance marks a critical milestone in our commitment to developing cost-effective therapies to patients with moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria.

The MAA is supported by a comprehensive data package, including extensive analytical, preclinical, pharmacokinetic, pharmacodynamic, safety, and immunogenicity studies demonstrating that ADL-018 is highly similar to the reference product, Xolair®, in terms of quality, safety, and efficacy.

"The MHRA’s acceptance of the MAA for ADL-018 brings us one step closer to offering patients in the UK a cost-effective alternative to Xolair®," said Chirag and Chintu Patel, Executive Chairman and Co-Founders of Kashiv Biosciences. "This acknowledgement by the MHRA underscores our dedication to expanding access to vital biologic therapies and addressing unmet medical needs."

“This represents an important step in the development of our proposed biosimilar to Xolair, with the key goal to increase patient access to an important biologic,” said Joseph McClellan, Chief Scientific Officer of Alvotech.

“We are pleased to see the MHRA’s acceptance of the MAA for ADL-018, which reflects the strength of our scientific collaboration and the shared vision to increase access to high-quality, affordable biologics,” said Dr. Nick Warwick, Chief Medical Officer at ADVANZ PHARMA. “This is a significant step forward in our mission to bringing biosimilar medicines to more patients across the UK and beyond.”

Kashiv Biosciences has a robust pipeline of biosimilar products, reflecting their deep commitment to delivering high-quality therapeutic options. The acceptance for ADL-018 aligns with the Company’s strategic goal to broaden the portfolio on a global scale.

About Kashiv:

Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application (MAA) for ADL-018, the Company’s proposed biosimilar for Xolair® (omalizumab)

Contacts