Sandoz strikes deal with EirGenix for Herceptin biosimilar

Sandoz has struck a deal with Taiwan-based EirGenix to market a late-stage biosimilar of Roche’s breast cancer blockbuster Herceptin.

The Novartis unit is playing catch-up with a gang of companies who already have their cheaper near-copies of Herceptin (trastuzumab) on the EU market and are ready to launch in the US once its US patent expires later this year.

This collaboration covers the medicine in phase 3 development for human epidermal growth factor receptor 2 positive (HER2+) breast and specific gastric cancer tumours.

EirGenix will maintain responsibility for development and manufacturing, and Sandoz has the right to market the medicine upon approval in all markets excluding China and Taiwan.

Herceptin’s patents expired in Europe in 2014, but competitors only managed to get their cheaper near-copies approved early last year, starting with Celltrion’s Herzuma in February last year.

Since then Allergan and Amgen, Pfizer, Biocon and Mylan have also had their competitors approved in the EU.

Four Herceptin biosimilars are also approved by the FDA in the US, but are unable to launch until the drug’s US patent expires in June this year.

However biosimilar launch dates are more of a movable feast in the US, where big pharma companies have been able to mount legal defences that hold off cheaper competitors even after their main patents have expired.

Any delays would play into the hands of Sandoz and EirGenix as they prepare to launch their version of Herceptin, which generated sales of around $6.9 billion last year.

Despite the other approved drugs, Sandoz said that “there continues to be a significant opportunity to introduce biosimilar competition to generate savings and increase access to this important medicine.”

Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said: “Introducing biosimilars can help create earlier and expanded access to this important medicine, which is why I am so excited about the potential for this collaboration.”

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