Polpharma Biologics discoverd first-of-its-kind Natalizumab biosimilar for the treatment of multiple sclerosis.
Natalizumab, the biosimilar aims to replicate the characteristics of the reference medication, including its dosage form, route of administration, dosing regimen, and presentation.
The development of this biosimilar represents a significant milestone for patients with multiple sclerosis, as it can potentially provide them with more accessible and affordable treatment options.
This approach is important to ensure that patients can transition to the biosimilar with minimal disruptions and continue to receive effective treatment.
Multiple sclerosis is a complex and challenging disease that requires lifelong management, and having access to cost-effective treatments can significantly alleviate the economic burden on both patients and healthcare systems.
The comprehensive analytical, preclinical, and clinical data submission to the EMA encompassed the Phase I and Phase III ANTELOPE trials involving patients with relapsing-remitting multiple sclerosis (RRMS).
Both studies successfully achieved their primary objectives, demonstrating that the biosimilar aligned with the reference medication in terms of effectiveness, safety, and immunogenicity.
Natalizumab is the second biosimilar developed and have been given the green light by the European regulatory authorities.