Polpharma Bio gets first EU okay for Tysabri biosimilar

Polpharma Biologics has said it is the first company to get approval in the EU for a biosimilar version of Biogen’s blockbuster multiple sclerosis therapy Tysabri.

The European Commission has approved the biotech’s biosimilar, now given the trade name Tyruko, for all Tysabri’s approved indications, including relapsing forms of multiple sclerosis. It will be commercialised by Sandoz, which is scheduled to be spun out of Novartis next month.

Sandoz acquired worldwide commercial rights to Tyruko in a 2019 deal with Polpharma Biologics, which is headquartered in the Netherlands, but with R&D operations in Poland. The biosimilar has the same strength/dosage form, intravenous route of administration, dosing regimen, and presentation as Tysabri.

Tysabri was Biogen’s top-selling drug last year, with total sales of just over $2 billion, although, it is already starting to come under pressure from increased competition in the relapsed MS market, with sales in the first half of the year falling 8%, even before biosimilars have become available.

Polpharma Biologics and Sandoz’s biosimilar was also approved for marketing last month in the US, which accounted for $1.1 billion of Tysabri’s 2022 sales. Europe accounted for an estimated $850 million of the total.

Last year, Polpharma Biologics and Sandoz won a patent challenge in Europe that resulted in the revocation of a key patent on Tysabri in the EU, slashing Biogen’s protection for the brand by more than five years. The company had expected the drug would not face biosimilar competition in Europe until at least 2027.

Biogen has been attempting to defend its franchise with a subcutaneous formulation, also given once a month. That was approved in the EU and UK last year, but didn’t make it past the FDA in the US, which turned it down in a complete response letter sent to Biogen last year. So far, there is no news on any attempt to refile in the US.

The main patents on Tysabri expired in the US and Europe in February, but various use patents claim protection until 2027 and some of these are still in dispute.

Adding to Biogen's challenges, meanwhile, is that its other MS blockbuster, Tecfidera (dimethyl glutamate), an oral therapy, is also being hit hard by generic competition.

Polpharma Biologics’ chief executive, Michael Soldan, said that the EU and US approvals mean that “millions of people living with multiple sclerosis around the world may soon have the option of a more affordable treatment for their disease.” A filing has also been made in the UK, with a decision due very soon.

Tyruko’s approval is a milestone for Polpharma Biologics, as it is the first developed entirely in-house. The biotech's first approved product – a biosimilar of Roche’s ophthalmology blockbuster, Lucentis (ranibizumab) – was developed by a joint venture with Formycon.