biosimilar

Tysabri biosimilar Tyruko now available in Germany for RRMS

TyrukoĀ (natalizumab), the first biosimilar ofĀ Tysabri,Ā is now available in Germany forĀ adults with highly active relapsing-remitting multiple sclerosis (RRMS). As a biosimilar, Tyruko has the same safety and efficacy profile, mechanism of action, and pharmacological properties as Tysabri. Biosimilars are typically sold at lower prices than their reference medication,…

Tyruko, first Tysabri biosimilar, approved in Europe for RMMS

The European Commission has approved Tyruko (natalizumab), the first biosimilar of Tysabri, for the treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). The approval makes Tyruko available in the European Union for the same indication as its reference medicine. It also marks the first approval…

Biosimilar Comparable in Safety, Efficacy to Tysabri in Phase 3 Trial

PB006, a biosimilar to Biogenā€™s approved treatment Tysabri (natalizumab), showed similar safety and efficacy as the original medication in peopleĀ with relapsing-remitting MS (RRMS), according to data from a Phase 3 clinical trial. “The Antelope trial reported equivalence between [PB006 and Tysabri] treatment across efficacy, safety, and secondary…

Guidelines for Approval of DMT Biosimilars, Use In Europe Drafted

Biosimilar, or ā€œfollow-on,ā€ forms of disease-modifying therapies (DMTs) that have been approved in a highly regulated area can be considered as safe and effective as their reference medications, according to multiple sclerosis (MS) experts. A biosimilar is a medication that’s highly similar to an existing biological medication in…

Natalizumab, Tysabri Biosimilar, Up for Approval in Europe

The European Medicines Agency (EMA) has agreed to review a request to approveĀ Polpharma Biologics‘ biosimilar natalizumab for the treatment of multiple sclerosis (MS). This marks the first time the regulatory agency accepted a marketing authorization application for a biosimilar of Tysabri, anĀ approved MS treatment. “The acceptance…