On July 24, 2023,Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), adopted a positive opinion regarding granting marketing authorization for natalizumab - a first-of-a-kind biosimilar for the treatment of multiple sclerosis. Biosimilar natalizumab was developed by Polpharma Biologics and will be commercialized by its collaboration partner Sandoz.

Upon approval, the marketing authorization for natalizumab would mirror the European indication for its reference medicine, a single disease-modifying therapy (DMT) used to treat adults with highly active relapsing-remitting multiple sclerosis (RRMS). Natalizumab was developed to have the same intravenous (iv) dosage form, route of administration, dosing regimen, and presentation as its reference medication. The robust analytical, preclinical, and clinical data submission package to the EMA included both the Phase I and Phase III ANTELOPE studies in RRMS patients.(1) Both trials met their primary endpoints, showing that the biosimilar matched the reference medicine in terms of efficacy, safety and immunogenicity.(1)

Multiple sclerosis is a progressive, chronic inflammatory and neurodegenerative disease of the central nervous system,(2) that can take a heavy toll on the lives of those affected and will need lifelong treatment. With the high costs of medication, broader access to more affordable treatment options is needed to reduce the substantial economic impact of multiple sclerosis to healthcare systems – estimated to be as much ?37,000-?57,000 per patient, per year in direct and indirect costs for those with moderate-to-severe disease.(3)

“The CHMP’s decision to recommend approval of this first-of-a-kind multiple sclerosis biosimilar is a milestone for patients who deserve affordable access to a treatment that could change the course of their disease. We are very proud that natalizumab is the second biosimilar from our Development and Production Center to have been given the green light by the European regulatory authorities,” said Michael Soldan, Chief Executive Officer, Polpharma Biologics Group.“We are now looking forward to supporting our partner Sandoz to bring biosimilar natalizumab to patients, whilst continuing to advance the development of our biosimilars pipeline which will broaden our ability to offer affordable access to life-changing medicines.”

A positive CHMP opinion is a scientific recommendation which is shared with the European Commission (EC) for the adoption of a decision on a European Union (EU) wide marketing authorization. An EC marketing authorization through the centralized procedure is valid in all EU Member States, as well as the European Economic Area countries Iceland, Liechtenstein, and Norway, and Northern Ireland under the Northern Ireland Protocol.

For Great Britain, a separate application for the use of biosimilar natalizumab in RRMS will immediately be made to the Medicines and Healthcare products Regulatory Agency (MHRA). The proposed biosimilar is also under review by the U.S. Food and Drug Administration (FDA).

Biosimilar natalizumab was developed by scientists at Polpharma Biologics and the company retains responsibility for the manufacturing and supply of the drug substance. Sandoz has the rights to commercialize and distribute the proposed biosimilar, upon approval, under an exclusive global license secured through a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019.

Polpharma Biologics is focused on broadening access to biological medicines used to treat some of the world’s most impactful diseases across neurology, immunology and ophthalmology. The company is at the forefront of the next wave in biopharma, leveraging its knowledge, capabilities and footprint to develop its robust pipeline of more than seven biosimilars in early-late-stage development.

About Polpharma Biologics

Polpharma Biologics is an international biotechnology company, with integrated operations in the European Union (EU), that leads in the development and manufacture of biosimilar medicines. Polpharma Biologics develops biosimilar therapies to treat a range of conditions in major therapeutic areas.

Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. Polpharma Biologics expertise lies in the development and manufacture of medicines based on microbial and mammalian expression systems.

With its cell line development center in the Netherlands, and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists.

References

1. Hemmer B, Wiendl H, Roth K, et al. Efficacy and safety of proposed natalizumab biosimilar PB006 versus Tysabri in patients with relapsing remitting multiple sclerosis: Primary data from the Phase III Antelope study (P6-4.003). Neurology. May 03, 2022; 98 (18 Supplement https://n.neurology.org/content/98/18_Supplement/1103)

2. MS International Federation. What is MS? October 2021. Available from: https://www.msif.org/about-ms/what-is-ms/ (Accessed June 2023)

3. Kobelt G, Thompson A, Berg J, et al. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler. 2017;23(8):1123-1136. doi:10.1177/1352458517694432