A biosimilar developed by Polpharma Biologics, Tyruko®, was unveiled as the first and only FDA-approved for the treatment of Multiple Sclerosis (MS) on 25 August 2023. The drug has not only been prescribed for the relapsing forms of multiple sclerosis, but also a potential therapeutic for Crohn’s disease (CD).
Multiple Sclerosis is an autoimmune disease that mainly impacts the components of the Central Nervous System (CNS). Damage to the myelin sheath of the neurons of the CNS impairs the communication to and from the brain, resulting in a plethora of divergent symptoms. According to a 2019 survey in US 400,000 individuals have said to have been affected by MS. Older prevalence studies have shown an approximate of 2.5 million cases globally, with 1 in every 100,000 Indian being diagnosed with the same. Crohn’s disease, on the other hand, is a chronic condition of the bowels resulting in inflammation of the gastro-intestinal (GI) tract. Tyruko® successfully induces substantive clinical response and recovery in patients with moderate to severe Crohn’s disease and are not suitable for conventional therapies.
“Near about one million people in the US are living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.”
-Keren Haruvi, President of Sandoz Inc., North America
Sandoz, originally a subdivision of Novartis, in collaboration with Polpharma Biologics launched a developed compound, natalizumab-sztn, for a round of vigorous clinical testing. Natalizumab-sztn is a biosimilar of an existing infusion therapy: Tysabri® (natalizumab), for the same condition. Tysabri®, a synthetically manufactured monoclonal antibody, retards the movement of immune bodies into the CNS. This shackled movement across the blood-brain-barrier aids in the treatment of neurodegenerative conditions like relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). The US Food and Drug Administration (FDA) granted Tyruko® its approval mainly due to its similarity to the reference drug Tysabri® in terms of safety and efficacy. The phase 3 study was conducted on a sample size of 264, With the biosimilar group of 131 participants and the reference group of 133 participants natatlizumab. This prescription can be used as a monotreatment for the first occurrence of MS symptoms as well as reoccurrence of symptoms after periodic stability with or without progression of the symptoms.
“Today’s approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,”
-Sarah Yim, Director of Office of Therapeutic Biologics and Biosimilars, FDA
In line with its commitment for a better healthcare and ambitions towards generic and biosimilar medicines, Sandoz signed a commercialization agreement in with Polpharma Biologics 2019. According to this agreement Polpharma Biologics will be responsible for the development, manufacture and supply the compound, while Sandoz will contribute in commercialisation and distribution. It is expected, Tyruko® to have a similar financial outcome as that of Tysabri®. According to a study conducted by Leonard D. Schaeffer, Centre for Health Policy & Economics, University of Southern California; The substantial sales of Tysabri resulted in massive $955.9 million, during the first half of 2023, from the earlier $1.04 billion of the prior year. Novartis experienced a 12.2% rise in shares compared to the industry growth of 7.6%
Carae Wagner specializes in reporting on the healthcare sector, with a specific emphasis on digital health, gene therapy, viral vectors, and public policy. She holds degrees in English and Psychology from the University of Virginia. Her writing has been featured in publications such as Forbes, Slate, C-Ville Weekly, and various others. She maintains a focus on anxiety disorders and depression and aims to explore other areas of mental health including dissociative disorders such as maladaptive daydreaming.