Remicade copies set for European entry
pharmafile | July 1, 2013 | News story | Sales and Marketing | CHMP, Hospira, Janssen, Remicade, arthritis, biosimilar
Janssen’s Remicade could soon come under generic pressure after a landmark recommendation by the CHMP.
South Korean biotech Celltrion and US firm Hospira have both been given the green light by the CHMP for biosimilar versions of autoimmune disease drug Remicade (infliximab). The drugs will be known as Remsima and Inflectra respectively.
The CHMP’s positive recommendation is a first for monoclonal antibody biosimilars, as well as the first generic form of Remicade.
If approved by the European Commission, which will most likely will be in the next three months, both drugs will be available in the EU for a number of autoimmune diseases.
They are also recommended as treatments for ulcerative colitis, ankylosing spondylitis, psoriasis, and psoriatic arthritis, rheumatoid arthritis and Crohn’s disease.
But because Janssen recently extended Remicade’s patent protection to 2015 in the majority of EU countries, Celltrion Hospira will only be able to introduce Remsima in a limited number of markets in 2014.
Mark Purcell an analyst at Barclays Plc, said that given this, the biosimilars could generate a maximum of $560 million in Europe sales.
Remicade, which made $6 billion last year for J&J’s pharma unit Janssen and partner Merck, is a monoclonal antibody (MAB), meaning it is notoriously difficult for other firms to copy.
Traditionally this has meant that MABs such as Remicade have not had to worry about the loss of patents, but firms prepared to create so-called biosimilars of these biological medicines are rising.
The cost of generics in Europe are usually around 70 – 90% less than their patented equivalents, but because regulators require firms to carry out limited clinical trials to prove the safety and efficacy of biosimilars, the price cut will not be as dramatic.
But savings are still to be had: speaking at the launch of its new drug, Kim Hyoung Ki, senior vice president at Celltrion, said: “The price of Remsima will be more than 30% cheaper than those of the original drugs.”
He added: “We’re confident in Remsima as it has price competitiveness, while it has the same effect as the original drugs.”
Despite the savings, both firms may still have an uphill struggle to shift their new products. Ronny Gal, an analyst at Sanford C. Bernstein & Co., said in a note to investors: “Even with regulatory approval, doctors may resist using the untested biosimilars.
“The task is now at hand to convince sceptical physicians to change their mind,” Gal added, citing conversations with gastroenterologists.
Ben Adams
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