Global drugmaker Mylan plans to launch a generic version of a drug used to treat rheumatoid arthritis and Crohn's disease on the Irish market that it estimates could save the HSE about €42 million a year.
On Thursday the European Commission granted marketing authorisation for a product called Hulio, a biosimilar to a drug from Abbott spin-off AbbVie. That drug, Humira, comes off patent on October 16th, with Mylan expecting to be ready to launch the generic version in the Republic either later this year or early in 2019.
Mylan partnered earlier this year with Tokyo-headquartered Fujifulm Kyowa Kirin Biologics to develop Hulio for sale to the European market.
The European Commission approval applies to all 28 European Union member States in addition to Norway, Iceland and Liechtenstein.
"We're very pleased with the decision of the European Commission to grant marketing authorisation for Hulio. This is the fourth product that Mylan will be bringing to market in the area of complex generics and biosimilars, and we're proud to be a leader in the market formation," said Mylan president Rajiv Malik.
Some 11,000 patients in the Republic take AbbVie’s drug for rheumatoid arthritis, and the HSE spends around €140 million per year on it – the most it spends on any drug.
Humira costs approximately €1,080 per month per patient, amounting to almost €13,000 per year. The drug is fully reimbursed by the State for all patients.
Mylan said its generic version would be 30 per cent cheaper, resulting in a saving to the HSE of €42 million a year were it to use the drug.
Savings
Owen McKeon, Mylan's country manager for Ireland, said: "Increasing use of biosimilars for Irish patients will drive significant savings for our health services, and provide faster and more affordable access for patients to life-enhancing medicines."
He called for the Department of Health to prioritise the publication and implementation of a biosimilars policy, something first promised by Minister Simon Harris in February 2017.
Mylan, which has a $19.7 billion market value, employs more than 1,700 staff in Ireland. It has research and development facilities in Dublin, and is the largest employer in the Galway Gaeltacht with its injectable product manufacturing facility.
