Humira set to face new European biosimilar rival

pharmafile | June 26, 2017 | News story | Sales and Marketing CHMP, EMA, Samsung Bioepis 

A position opinion from the EMA for Samsung Bioepis’ biosimilar of Humira looks set to unleash a second rival to the best-selling drug, after Amgen had also received approval for its biosimilar. The biosimilar has been named Imraldi boosts the prospects of the company and its partner Biogen, which is responsible for the marketing of the product in Europe.

The EMA’s CHMP decisions are largely followed by the European Commission, which means that Samsung Bioepis could well have three biosimilars reach market in Europe and the US in the five short years the company has been in operation. It is currently able to sell a Remicade and Enbrel biosimilar, and it looks like it could soon be able to add Humira to this list.

AbbVie currently has a strong raft of patent-protection on Humira but its main patents are set in October 2018. This date looks set to be the key test for the company to see whether it can protect its drug from a raft of potential biosimilar competition. For its part, the company has suggested that it is placed to be able to protect the drug all the way through into 2022.

It will be hoping that it is able to protect sales that far, as the drug was responsible for $16 billion in sales last year alone; the drug is responsible for 60% of the company’s revenue alone.

“We welcome the EMA’s positive recommendation for Imraldi, which brings us a step closer to delivering a lower-cost, high-quality autoimmune treatment option to patients across Europe,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars.”

Ben Hargreaves

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