biosimilar

Tyruko (natalizumab-sztn) is now commercially available in the U.S. as the first and only approved biosimilar to Tysabri for adults with relapsing forms of multiple sclerosis (MS). The therapy received approval from the U.S. Food and Drug Administration (FDA) in 2023 for all indications covered by the…

Three biosimilar drugs — approved versions of brand-name therapies that have no clinically meaningful differences compared with their reference products — including one for multiple sclerosis (MS), will soon be available in the Middle East and North Africa (MENA) region under a new partnership between two pharmaceutical companies.

Alvotech, a developer of biosimilar medicines, is expanding its partnership with Advanz Pharma to commercialize three new products in Europe — one of them a biosimilar of Kesimpta (ofatumumab), a drug used for treating multiple sclerosis (MS). Biosimilars are therapies that have no clinically meaningful differences…

Tyruko (natalizumab), the first biosimilar of Tysabri, is now available in Germany for 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,…

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…

The late August approval of Tyruko (natalizumab-sztn) by the U.S. Food and Drug Administration (FDA) is big news in the multiple sclerosis (MS) world. Tyruko is a biosimilar for Tysabri (natalizumab), and it’s the first biosimilar to gain FDA approval as an MS disease-modifying therapy…

The U.S. Food and Drug Administration (FDA) has approved Tyruko (natalizumab-sztn) as the first biosimilar of Tysabri to treat adults with relapsing forms of multiple sclerosis (MS). The decision also marks the first approval of any biosimilar for MS in the country, according to the regulatory agency.

PB006, a biosimilar to Biogen’s approved treatment Tysabri (natalizumab), showed similar safety and efficacy as the original medication in people 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…

Biosimilar, or “follow-on,” 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…

The U.S. Food and Drug Administration (FDA) has agreed to review an application requesting that Polpharma Biologics‘ natalizumab, a biosimilar of Tysabri, be approved to treat relapsing forms of multiple sclerosis (MS). Its intended U.S. use is for the same indications as the approved name-brand medicine, covering clinically isolated…

The European Medicines Agency (EMA) has agreed to review a request to approve 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, an approved MS treatment. “The acceptance…

Truxima, a biosimilar of rituximab, is comparable to the originator therapy in terms of effectiveness and safety for treating multiple sclerosis (MS), a new study suggests. Rituximab — marketed as Rituxan in the United States — is an antibody-based therapy that works by killing B-cells, which are immune cells…

Sandoz, a division of Novartis dedicated to the development of biosimilars, has entered an agreement with Polpharma Biologics, a biopharmaceutical company also dedicated to the manufacture of biosimilars, to develop and market a biosimilar to Biogen‘s Tysabri (natalizumab). Tysabri is a disease-modifying therapy (DMT) that was …

Worldwide Clinical Trials has added two webinars to its free webinar series — the first to observe Multiple Sclerosis Awareness Month in March and the second for Parkinson’s Awareness Month in April. Although both are free, attendees need to sign up in advance (see the link below). The first informative session will take place…