New generic version of Zeposia could lower cost of MS treatment
Formulation will be manufactured, supplied by Synthon, upon final approval
A generic formulation of Zeposia (ozanimod), which won tentative approval for treating multiple sclerosis (MS) from the U.S. Food and Drug Administration (FDA), will be manufactured and supplied by Synthon, based in the Netherlands.
Tentative approval means the generic version has met all FDA requirements for safety, efficacy, and quality, but can’t be marketed yet because of existing patent protections or exclusivity rights held by the brand-name drug.
Synthon was one of the first companies to apply a Zeposia generic, making it eligible for a shared 180-day exclusivity once the generic can be sold. During this time, first-filer companies may share a temporary period where no other generics can enter the market, giving them a head start in offering the medication to patients.
Zeposia is a small molecule approved in the U.S. for adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
The announcement follows a licensing and supply agreement between Synthon and Zydus Lifesciences Global FZE, a subsidiary of the generic’s developer, Zydus Lifesciences.
Generic Zeposia may improve access
Under the deal, Synthon will secure final FDA approval and then manufacture and supply the medication. Meanwhile, Zydus will market the generic in the U.S.
“This collaboration with Synthon enables us to bring this important treatment to the U.S. market,” Punit Patel, president and CEO of Zydus Pharmaceuticals (USA), said in a company press release. It “reinforces our strategic focus on advancing care in therapeutic areas and reflects our commitment to making essential medicines more accessible to patients.”
Zeposia works by modulating sphingosine-1-phosphate (S1P) receptors on the surface of specific immune cells that are needed for the cells to leave lymph nodes, where some immune cells, including those that drive MS inflammation, are matured and stored.
By keeping the immune cells in the lymph nodes, Zeposia reduces the number that can reach the brain and cause damage. Clinical studies show this can reduce the frequency of relapses and the development of new brain lesions.
While Zeposia provides a vital treatment option for people with relapsing forms of MS, it’s often expensive, with a list price of more than $9,000 for a month’s supply.
Generics are usually less expensive versions of a brand-name medication. They contain the same active substance as their approved reference medicine and are used at the same dose for the same patient group. By lowering costs, they could help improve access to treatment.
“This collaboration with Zydus for ozanimod capsules continues to underscore our proven expertise in developing first-to-market, complex generic products. We are pleased to strengthen our partnership with Zydus as we continue advancing our strategic commitment to expanding access to essential medicines,” said Anish Mehta, Synthon’s CEO.
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