Biopharma Business

Doctors and not pharmacies should retain control of any decision to switch a patient from a modern biologic medicine to a biosimilar version, the industry has argued.

In its submission to the National Biosimilar Medicines Policy, the Irish Pharmaceutical Healthcare Association (IPHA) says the current rules allow for adequate access to the Irish market for biosimilar drugs.

It argues that high savings in drug bills can still be achieved even if biosimilar market share is low.

Biosimilars are copies of modern biologic drugs, derived form living organisms, that have “no clinically meaningful differences in terms of safety and effectiveness from the reference product”. However, they are not precise copies in the way that generic drug.

Innovative medicines

The IPHA says the focus must be on bringing innovative medicines to patients as quickly as other countries in Europe currently do.

“Currently we are last among western European countries on the adoption of new medicines, IPHA chief executive Oliver O’Connor, said. “This must be fixed.”

The IPHA, which represents 44 research-based pharma companies – including some that operate in both the original and biosimilar/generics market – said it supports competitive pricing in “post-patent markets” to allow the health service to invest in new medicines. It pointed to the provision in the current drug-pricing agreement where the price of the original biologic medicine falls 30 per cent when a competitor biosimilar enters the Irish market.

But where Irish law now allows for generic substitution by pharmacists, the IPHA has come out against extending the practice to biosimilars.

“Pharmacy-led substitution of these medicines is neither needed not appropriate,” the submission states. It argues this is in line with standard practice across Europe.

The IPHA submission also rejects the idea of market-share quotas for biosimilar products.