Sandoz, Novartis’ generics unit, has agreed to license a biosimilar of Biogen’s Tysabri for multiple sclerosis from Polpharma Biologics.
The drug is currently in phase 3 clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS). Polpharma will maintain the responsibilities for the development, manufacturing and supply of the drug, with Sandoz set to commercialise and distribute the medicine once it is approved.
According to Novartis, affordability is a significant challenge for MS medicines, with a recent report highlighting that it is the most common challenge affecting access to MS therapy in 46% of 90 countries.
“Patient access to advanced medicines is important for all people diagnosed with a chronic disease, but the challenges are very pronounced for MS patients,” said Pierre Bourdage, ad interim global head of biopharmaceuticals, Sandoz.
“By nature, biosimilars create competition and cost savings, which are proven to make room in healthcare systems to treat more patients,” he added.
The biosimilar franchise in Europe has grown in recent years, thanks to patent expirations on blockbusters such as Tysabri. Sandoz’s sales in the second quarter of 2019 climbed 3% to $2.4bn, with double-digit gains in Europe for its trio of biosimilars rixathon (rituximab), hyrimoz (adalimumab) and erelzi (etanercept). However, the market in the US has not been as quick on the uptake, with drugmakers defending named versions and blocking marketing applications of generics.
Sandoz has been the subject ofone such case, following a US court ruling in favour of Amgen regarding a dispute between the two companies over patents protecting Enbrel (etanercept) from biosimilar competition. Despite Sandoz gaining approval in 2016for erelzi, its biosimilar version of the rheumatoid arthritis drug, it has been unable to introduce the drug due to the ongoing patent litigation.
Despite the setback, Novartis is continuing to expand its generics division, with natalizumab its fifth proposed biosimilar in nine months. It also adds to Novartis MS franchise, following the approval of Mayzent earlier this year. It is the first drug approved in the US to treat disease progression in patients with active secondary progressive multiple sclerosis (SPMS).
The Swiss drugmaker also recently revealed promising data from another pipeline MS candidate, ofatumumab, and has plans to start filing the drug with health authorities for approval by the end of the year.