HQ Team
August 25, 2023: The US drug regulator gave its nod for Sandoz Inc., an arm of Sweden-based Novartis and which is set to be Europe’s largest generic drugmaker, for a biosimilar, Tyruko, to treat adults with multiple sclerosis.
The USFDA approved Tyruko, (natalizumabsztn), the first biosimilar to Tysabri (natalizumab) injection — also used for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease and inflammation.
Biosimilars are biological medical products that are almost identical copies of the original product made by a different company and already approved by the FDA (reference product). They are officially approved versions of original “innovator” products and can be manufactured when the original product’s patent expires.
This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.
Lower cost
“Today’s approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA’s longstanding commitment to supporting a competitive marketplace for biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars at FDA’s Center for Drug Evaluation and Research.
The approval “ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”
Tyruko was approved to treat clinically isolated syndrome – a single, first occurrence of MS symptoms, and relapsing-remitting disease – a type of MS that occurs when patients have episodes of new neurological symptoms followed by periods of stability.
The biosimilar can treat active secondary progressive disease – when, following a relapsing-remitting course, patients experience gradual disability worsening with continued relapses.
Autoimmune disease
Multiple sclerosis is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other body parts.
It is among the most common causes of acquired neurological disability in young adults and occurs more frequently in women than men.
For most people with MS, episodes of worsening function and the appearance of new symptoms, called relapses, are initially followed by recovery periods (remissions).
Over time, recovery may be incomplete, leading to a progressive decline in function and increased disability.
Boxed warning
The FDA nod contains a boxed warning to inform healthcare professionals and patients about the increased risk of progressive multifocal leukoencephalopathy , a viral infection of the brain that usually leads to death or severe disability.
The Novartis’ Sanzon spin-off was slated to happen in H2 2023 after Novartis decided last year to separate its biosimilars and generic business. An extraordinary general meeting is scheduled for September 15, 2023.
In August last year, Novartis stated that it planned to change Sandoz into a publicly traded, standalone business.
