The BLA submission includes all indications covered by the reference medicine Tysabri (natalizumab) for relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults, and Crohn's Disease.
Sandoz entered into a global commercialization agreement on that biosimilar in 2019 with Polpharma Biologics, a company with facilities in Gdańsk and Warsaw in Poland and Utrecht in the Netherlands, whereby Polpharma maintains responsibility for development, manufacturing and supply, and Sandoz, through an exclusive global license, has the rights to commercialize and distribute the product in all markets.
The biosimilar has been developed to have the same intravenous dosage form, route of administration, dosing regimen and presentation as the reference medicine, said Sandoz, which is the biosimilars division of Novartis.
Earlier this month saw the European Medicines Agency (EMA) accept a marketing authorization application (MAA) for the same biosimilar, covering treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EMA for Tysabri.
Treatment cost and lack of access to effective treatment can create an additional burden for people with MS, their families and healthcare systems.
“Thanks to advances in medicine over the last 20 years, we now have DMTs, which have become a cornerstone in the treatment of MS. However, access to affordable, high-quality treatment options is still a challenge,” said Florian Bieber, global head of biopharmaceuticals development, Sandoz. “This is the first and only submission for a biosimilar natalizumab medicine in both the US and Europe. If approved, this biosimilar has the potential to increase access while also delivering savings for healthcare systems.”
The BLA and MAA include a comprehensive analytical, preclinical, and clinical data package, reported Sandoz. The Phase I and Phase III Antelope studies in RRMS patients met their primary endpoints, showing that the biosimilar matches the reference medicine in terms of efficacy, safety, and immunogenicity, it added.
Humira biosimilar also on FDA desk
Sandoz has been busy on the regulatory front.
Last week saw it announce that the FDA had accepted its supplemental biologics license application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.
Hyrimoz HCF (adalimumab-adaz), if approved, would help expand access to more patients with serious inflammatory diseases, said Keren Haruvi, president, Sandoz Inc.
The sBLA includes the indications of the reference medicine, Humira, not protected by orphan exclusivity including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
The EMA also accepted an application for Hyrimoz HCF in June this year.
In tandem with its regulatory push, Sandoz recently announced a new initiative aimed at improved access for biosimilars in global markets.
The ‘Act4Biosimilars’ organization wants to see increased adoption of biosimilars by at least 30% in over 30 countries by 2030, by targeting ‘four As’: approvability, accessibility, acceptability and affordability.