Biosimilars manufacturers close in on Roche cancer blockbusters

Roche’s blockbusters Herceptin and Avastin could face cheaper biosimilar competition in the US after FDA advisers unanimously backed their safety and efficacy.

The regulator is not bound to follow the advice of its advisers – but it usually does, making regulatory approval likely.

In both cases, the drugs from Mylan/Biocon and Amgen/Allergan got unanimous backing from the panel of experts from the FDA’s Oncologic Drugs Advisory Committee (ODAC).

But due to the litigious nature of the originator companies, getting cheaper rivals to market in the US can often be problematic.

There are issues with patent law in the US that may keep biosimilars off the US market for another couple of years.

US patents on Herceptin and Avastin are due to expire by 2019, but in many cases, originator manufacturers will defend their products with additional patent protections that can keep rivals at bay for longer.

However the US Supreme Court last month ruled that biosimilar manufacturers don’t have to wait for six months after approval to market their product, removing another potential delay to the launch of biosimilar competitors.

Global sales of Herceptin and Avastin both approach $7 billion. In 2016, US sales of Herceptin were around $2.6 billion and Avastin generated about $3 billion, so the stakes are high for Roche.

Earlier this week, Mylan’s development partner Biocon said the EU launch of the Herceptin biosimilar will be delayed because its manufacturing facility in Bangalore needs to be re-inspected to ensure it complies with regulations.

Mylan president Rajiv Malik said: “We look forward to working with FDA to further increase access to this important treatment option for the thousands of patients affected by HER2-positive breast cancer each year."

Amgen is collaborating with Allergan to bring four oncology biosimilars to market, and the Avastin biosimilar is the most advanced in the pipeline.

Other cancer biosimilars in Amgen’s pipeline include rivals to Merck KGaA’s Erbitux (cetuximab), Roche’s MabThera/Rituxan (rituximab) and Herceptin.