Novartis set to expand its generic franchise with Biogen biosimilar


Novartis’s generic sub-unit Sandoz has agreed to license a biosimilar of Biogens Tysabri for Multiple Sclerosis from Polpharma Biologics.

The drug is currently in phase three trial and Polpharma will maintain the responsibility for the development, manufacturing and supply of the product while Sandoz will takeover the commercialization and distribution.

Novartis has decided to take this action as according to them, affordability is the biggest challenge facing MS treatments, with a recent report highlighting that it is the most common challenge affecting access to MS therapy in 46% of 90 countries. With Pierre Bourdage, interim global head of biopharmaceuticals commenting: “ By nature, biosimilars create competition and cost savings, which are proven to make room in healthcare systems to treat more patients.”

Generics have seen a huge surge in growth in Europe, with thanks to patent expirations that have occurred in the past few years. This is shown by Sandoz figures from the second quarter, with sales climbing up 3% to $2.4bn. However the uptake has not been as quick in the US, where drugmakers are defending branded versions and blocking generic marketing applications with a fierce ferocity.
This is a story Sandoz know too well, with Sandoz losing a US court ruling against Amgen over a dispute between the two companies regarding patent protection over Amgen’s blockbuster Enbrel. Despite Sandoz gaining approval for its biosimilar version in 2016, it has not been able to introduce the drug due to ongoing patent litigation.

This setback has not held Novartis back as it continues to expand its generics division, with natalizumab its fifth proposed biosimilar in nine months. Novartis is also seeing success in its MS franchise, with an approval of Mayzent this year and reporting of promising data for another pipeline MS candidate, ofatumumab, which it starts to plan filing for approval to health authorities by the end of this year.

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