Sandoz, a global leader in generic and biosimilar medicines, announced today the EU approval for Tyruko® (natalizumab), the first and only biosimilar produced by Polpharma Biologics for commercialization.
The authorisation covers treatment as a single disease-modifying therapy (DMT) in adults with very active RRMS, the same indication as the reference drug Tysabri® (natalizumab) approved by the EU.
Agreement between Polpharma Biologics and Sandoz:
Sandoz and Polpharma Biologics signed a global commercialization agreement for biosimilar natalizumab in 2019. Polpharma Biologics will retain responsibility for medicine discovery, manufacture, and drug substance supply under this agreement. Sandoz owns the unique global licence to commercialise and distribute it in all markets.
Basis of EU Approval of Tyruko:
In addition to results from a Phase I PK/PD study and a confirmatory Phase III Antelope study in RRMS patients, the entire regulatory filing package contained information from an extensive analytical and functional assessment.
Both studies achieved their primary endpoints, indicating that the biosimilar is equivalent to the reference biologic in terms of pharmacokinetics, effectiveness, safety, and immunogenicity.
Tyruko® has the same strength/dosage form, IV method of administration, dosing schedule, and presentation as the reference drug.
About Multiple Sclerosis:
MS is a chronic inflammatory and neurodegenerative central nervous system illness that can have a significant impact on daily living. Most patients with MS suffer relapses, which are periods of new or worsening symptoms followed by periods of disease remission, when symptoms improve partially or completely.
Early DMT treatment can alter the course of a person’s MS and lessen future impairment. According to the Atlas of MS Report, access to DMTs is not ubiquitous; 72% of nations mention challenges to receiving DMTs, and the cost of MS medications is a barrier to access in many countries.
About Sandoz:
Sandoz is dedicated to ensuring that millions of patients have access to vital and potentially life-changing biologic medicines in fields such as immunology, cancer, supportive care, and endocrinology in a sustainable and cost-effective manner.
With eight marketed biosimilars and another 25 assets in various stages of development, it has a leading global portfolio. Sandoz has contributed to enable early and increased patient access to life-changing medicines while increasing healthcare savings and creating competition that feeds further discovery since delivering the first biosimilar in Europe in 2006.
About Tyruko Biosimilar:
Tyruko® was created to be similar to the reference drug, a well-established, very successful anti-4 integrin monoclonal antibody used as a disease-modifying treatment in relapsing types of multiple sclerosis (MS).
Tyruko is approved in the European Union as a single disease-modifying medication (DMT) in people with relapsing-remitting multiple sclerosis (RRMS).
