February 2, 2024 News by Patricia Inacio, PhD 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,…
September 28, 2023 News by Andrea Lobo, PhD 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…
September 1, 2023 Columns by Ed Tobias The 1st biosimilar OK’d as an MS DMT should save patients money 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…
August 28, 2023 News by Lindsey Shapiro, PhD Tyruko, first Tysabri biosimilar, cleared in US to treat relapsing MS 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.
February 3, 2023 News by Marisa Wexler, MS Biosimilar Comparable in Safety, Efficacy to Tysabri in Phase 3 Trial PB006, a biosimilar to Biogenās 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…
August 26, 2022 News by Lindsey Shapiro, PhD Guidelines for Approval of DMT Biosimilars, Use In Europe Drafted Biosimilar, or āfollow-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…
July 27, 2022 News by Margarida Maia, PhD Natalizumab, Biosimilar of Tysabri for Relapsing MS, Under FDA Review The U.S. Food and Drug Administration (FDA) has agreed to review an application requesting thatĀ Polpharma Biologics‘ natalizumab, a biosimilar of Tysabri, be approved to treat relapsing forms ofĀ multiple sclerosis (MS). Its intended U.S. use is for the same indications as the approved name-brand medicine, coveringĀ clinically isolated…
July 19, 2022 News by Marisa Wexler, MS 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…
April 1, 2020 News by Marisa Wexler, MS Biosimilar Truxima Works as Well as Rituximab Originator in MS, Study Finds Truxima, aĀ biosimilar of rituximab, is comparable to the originator therapy in terms of effectiveness and safety for treatingĀ multiple sclerosis (MS), a new study suggests. Rituximab āĀ marketed asĀ RituxanĀ in the United States ā isĀ an antibody-based therapy thatĀ works by killing B-cells, which are immune cells…
September 5, 2019 News by Joana Carvalho, PhD Sandoz Enters Agreement with Polpharma Biologics to Develop and Commercialize Tysabri Biosimilar 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‘sĀ Tysabri (natalizumab). Tysabri is a disease-modifying therapy (DMT) that wasĀ …
March 22, 2017 News by Patricia Silva, PhD Worldwide Clinical Trials to Host Free Webinar on Biosimilars for MS Awareness Month Worldwide Clinical TrialsĀ has added two webinars to its free webinar seriesĀ ā the first to observeĀ Multiple Sclerosis Awareness MonthĀ in March and the second for Parkinsonās Awareness MonthĀ in April. Although both are free, attendees need to sign up in advance (see the link below). The first informative session will take place…