The European Generic Medicines Association (EGA) has hit back at efforts by the research-based industry to sow doubts about the safety, quality and comparability of biosimilar medicines as a real market for follow-on versions of biotechnology products starts to emerge in the European Union.

Earlier this month, Labour MP Dr Brian Iddon told the UK’s House of Commons that biosimilars should carry the Medicines and Healthcare products Regulatory Agency’s (MHRA) ‘black triangle’ symbol, indicating that a medicine should be intensively monitored for adverse drug reactions. A review panel led by Dr Iddon has also called for an “urgent ban” on pharmacist substitution of biosimilars until effective safeguards are in place.

The review of biosimilars conducted by Dr Iddon and four other UK parliamentarians late last year was funded by Amgen. The British Generic Manufacturers Association (BGMA) has complained that it was not asked to contribute.

Addressing the 6th EGA Symposium on Biosimilar Medicines in London last week, director general Greg Perry insisted that the use of “scare tactics” against biosimilar medicines must cease. According to the EGA, these tactics have included “misrepresenting an event recently organised in the UK Parliament by the originator industry as a formal parliamentary review”.

World leader

Perry congratulated industry and regulatory authorities for further consolidating and developing “biosimilar thinking” in the EU during 2007. “This rigorous scientific approach has firmly established the EU as the world leader in biosimilar medicines”, he pointed out.

With 10 new applications in each category, biosimilar and generic medicines made up 22% of all submissions to the European Medicines Agency (EMEA) through the centralised approvals procedure in 2007.

On the biosimilars front, there were significant breakthroughs in the form of market clearance for biosimilar epoetin alfa products (erythropoietin - Johnson and Johnson’s Eprex/Amgen’s Epogen) and positive scientific opinions from the EMEA for biosimilar versions of filgrastim (granulocyte colony-stimulating factor – Amgen’s Neupogen).

The important question, though, was how quickly now patients in Europe could benefit from the EU’s lead, Perry told the symposium. The key was to develop appropriate market pathways for biosimilars.

This meant reinforcing the confidence of patients and healthcare professionals in the EU’s approval process for biosimilars by informing all stakeholders that follow-on products were manufactured to the same quality standards (i.e., Good Manufacturing Practice) as other current biopharmaceuticals, that therapeutic equivalence to the reference biopharmaceutical had been proven scientifically, that clinical efficacy and safety had been demonstrated in clinical studies, and that monitoring of biosimilars was the same as for any other new biopharmaceutical.

If biosimilars were really to take hold in Europe, Perry added, there needed to be active support from EU and national authorities for the Union’s unique “Biosimilar Philosophy”, as well as fine-tuning of the EU pharmacovigilance framework. Member states should also establish pricing and reimbursement structures that encouraged the market entry of biosimilar medicines and the price competition they offered.

Ensuring increased patient access to biosimilars was a shared responsibility that must be taken up proactively by industry, the medicines authorities and healthcare professionals throughout Europe, Perry stressed.