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Row over savings to State from ‘copycat’ drugs

Generics lobby says biosimilars are being blocked but pharma group disagrees

Arrival of biosimilars is expected to deliver savings of more than €100m over the four-year life of the agreement

The Irish healthcare system must do more to encourage competition by generic and biosimilar drugs if it is to cut Ireland’s drug bill and provide funds for new medicines, a conference will be told on Wednesday.

Speakers at the conference, organised by the Healthcare Enterprise Alliance (HEA), claim current measures are failing to deliver the best possible value for Irish healthcare budgets, and for patients.

The HEA represents the generics and biosimilar sectors in Ireland. It claims that lack of support for proper market access is effectively blocking their drugs from entering the Irish market and bringing prices for the Health Service Executive and private patients down.

Their claims have been dismissed by the Irish Pharmaceutical Healthcare Association (Ipha) which says the recently-agreed drug pricing agreement was delivering significant savings.

Oliver O’Connor, chief executive of Ipha, which represents the big research-focused pharmaceutical companies, dismissed claims that the accord between Ipha, the HSE and Government was essentially blocking the uptake of biosimilars.

“The Ipha agreement is now delivering savings of €12 million a month since it started on August 1st and is on target for €140 million [in savings] in its first year,” he said. “It is travesty for others to suggest we are not delivering value.”

Biosimilar

The agreement, among other things, provides that branded modern biologic drugs must cut their price by 30 per cent when a biosimilar is approved and enters the Irish market. A biosimilar is a drug that closely replicates the original biologic drug and has no clinically meaningful differences in terms of safety and effectiveness.

The HEA cites the experience of Benepali, a rheumatoid arthritis drug, which was the first biosimilar introduced to the Irish market following the signing of a new Framework Agreement on Supply and Pricing of Medicines last summer. Just three packets of the drug have been sold in Ireland compared to almost 10,000 of the established rival brand, Pfizer’s Enbrel, in the period.

That experience, the HEA argues, will deter other biosimilars from entering the Irish market in which case there will be no 30 per cent saving on the existing branded drugs with which they would compete.

Mr O’Connor says the arrival of biosimilars is expected to deliver savings of more than €100 million over the four-year life of the agreement out of total savings projected by Ipha to come to €785 million.

“Savings from the entry of biosimilars into Ireland are part of this package and have already started,” he said

As investment in the development of a biosimilar is significantly less than an originator biologic [medicine], Mr O’Connor said, the State should expect a biosimilar manufacture to launch with at least a 30 per cent discount.

“The 30 per cent price cut is providing the State with savings already. These savings are not contingent on the subsequent uptake or market share of biosimilars. Ipha agreed this mechanism specifically so that the State can invest in new medicines,” Mr O’Connor said.

“The pricing agreement Ipha negotiated with the State is working and is delivering very substantial savings to the State,” Mr O’Connor said.