An international biotech, with headquarters in Amsterdam, has announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for its biosimilar product.
Polpharma Biologics, which is dedicated to the development of biosimilars, announced on Friday (July 15) that natalizumab, similar to Tysabri, which treats multiple sclerosis, has been accepted as a proposal.
The application is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as Tysabri – a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS).
A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original “innovator” products and can be manufactured when the original product’s patent expires.
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease that can take a heavy toll on the quality of life of those affected. Within ten years of diagnosis, up to half of those will have to stop working, within 15 years they will need mobility aids and within 25 years they will no longer be able to walk. Treating the disease is expensive with the burden costing between €37-57k ($35.4-57.7k) per patient per year for those with moderate to severe MS.
The MAA submission was supported by a robust analytical, preclinical and clinical data package, including evidence from the phase 3 Antelope study in RRMS patients. The Antelope study, plus an earlier phase 1 trial, both met their primary endpoints, demonstrating that the proposed biosimilar matched the efficacy and safety of the reference medicine.
Biosimilar natalizumab was developed by scientists at Polpharma Biologics and the company retains responsibility for the manufacturing and supply of the medicine. Sandoz, a division of Novartis, has the rights to commercialize and distribute the proposed medicine under an exclusive global license, secured through a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019.
CEO, Michael Soldan, said: “The acceptance of the filing of proposed biosimilar natalizumab by the European regulatory authorities means we are a critical step closer to getting this important medicine to the patients who need it the most. We are deeply proud of the dedication of our scientific teams to take biosimilar natalizumab from cell line and technical development, through clinical trials to registration – today’s milestone is testament to their achievements.”
Natalizumab is the second proposed biosimilar from Polpharma’s pipeline and comes after another medicine ranibizumab, a monoclonal antibody fragment sold under brand name Lucentis which was successfully filed in Europe in the past year.
Polpharma Biologics said it is focused on developing biosimilar therapies to treat some of the world’s most impactful diseases across neurology, immunology and ophthalmology. The company’s pipeline contains more than six biosimilars in different stages of development.