Sandoz Secures Global Commercialization Rights for Natalizumab Biosimilar Targeting RRMS

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Sandoz, a Novartis company, recently announced that it has signed a global commercialization agreement with the European biopharmaceutical company Polpharma Biologics for a natalizumab biosimilar. The drug is currently in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS). Under the agreement, Polpharma will continue to be responsible for the development, manufacturing, and supply of the natalizumab biosimilar. Upon regulatory approval, Sandoz will commercialize and distribute the product in all markets through an exclusive global license. Other terms of the agreement are confidential. The addition of this biosimilar will expand Sandoz’s portfolio, which covers immunology, oncology, and endocrinology, with eight biosimilars already on the market and more than ten others in development.

The reference product for this biosimilar is Biogen’s blockbuster drug Tysabri (natalizumab), a biologic disease-modifying therapy (DMT) that was approved for market entry over a decade ago, providing a valuable treatment option for patients with relapsing-remitting multiple sclerosis (RRMS). In 2018, global sales of Tysabri amounted to $1.864 billion.

Multiple Sclerosis (MS): Beyond the personal burden on patients and their families, affordability represents a major challenge for MS medications. A recent report highlights that in 46% of the 90 countries surveyed globally, affordability is the most common barrier to accessing MS treatments.

Multiple sclerosis (MS) is an autoimmune disease of the central nervous system that disrupts the normal function of the brain, optic nerves, and spinal cord through inflammation and tissue damage, affecting approximately 2.3 million people worldwide. MS is typically classified into three types: relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS), and primary progressive multiple sclerosis (PPMS). Approximately 85% of patients initially present with the relapsing form of MS.

In this field, Novartis’s product portfolio includes Gilenya, Mayzent, and Extavia. Additionally, Sandoz is marketing Glatopa in the United States, a generic version of Teva’s Copaxone.

Among the aforementioned drugs, Gilenya (Jielingya^®) was included in the first batch of the “List of Clinically Urgent Overseas New Drugs” by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in 2018, and received approval in China this July for the treatment of relapsing multiple sclerosis in patients aged 10 years or older. This drug is the first and only disease-modifying therapy that covers pediatric, adolescent, and adult patients with multiple sclerosis.

In the field of multiple sclerosis (MS), Novartis is also developing another antibody drug, ofatumumab. Data from two head-to-head Phase III clinical trials (ASCLEPIOS I and II), released at the end of last month, showed that both studies met their primary endpoints: as assessed by the annualized relapse rate, compared with Sanofi’s once-daily oral medication Aubagio^®) compared with, once-monthly subcutaneous injections of 20 mg ofatumumab demonstrated a highly significant and clinically meaningful reduction in the number of relapses, while also significantly delaying the time to disability progression.

Ofatumumab is a monoclonal antibody drug targeting CD20, approved for the treatment of chronic lymphocytic leukemia and marketed under the brand name Arzerra. Novartis has assigned a new development code, OMB157, to ofatumumab as it develops the drug as a next-generation B-cell depleting agent. This agent features more rapid B-cell depletion and potentially favorable safety profiles that preserve immunity, while also offering the convenience of once-monthly subcutaneous administration.

Ofatumumab is poised to challenge Roche’s CD20-targeted antibody drug, Ocrevus, which is the first and only medication approved for the simultaneous treatment of relapsing multiple sclerosis (RMS)—including clinically isolated syndrome, relapsing-remitting multiple sclerosis (RRMS), and active or relapsing secondary progressive multiple sclerosis (SPMS)—and primary progressive multiple sclerosis (PPMS). Administered via intravenous infusion every six months, with only two infusions required per year, Ocrevus significantly improves patient treatment adherence. Since its approval in March 2017, Ocrevus sales have surged sharply, reaching CHF 2.353 billion in 2018. In the first half of this year, Ocrevus generated sales of CHF 1.735 billion, representing a 63% year-over-year increase.

References:

1、Novartis expands its generics franchise with natalizumab biosimilar

2、Novartis vies for multiple sclerosis dominance with Arzerra trial

3. Websites such as Roche, Novartis, Biogen, and Sina Medicine