With regulations covering biosimilar medicines falling into place around the world, there is a need to reach global agreement on criteria and guidelines for such products, say European generics industry leaders.

With progress in the US, Australia, Canada, Japan, Turkey and other countries already armed with a regulatory framework for biosimilars, the time is approaching to undertake a benchmarking exercise, Greg Perry, director general of the European Generic Medicines Association (EGA), told an industry meeting in London recently. A consistent, scientific global approach is essential in order to move towards true global development for biosimilar medicines, he added.

A thorough comparability exercise with the reference product is essential to demonstrate that biosimilars – also know as “follow-on biologics” - match their reference products in terms of quality, safety and efficacy and to reassure patients and healthcare professionals, Mr Perry told the meeting.

“If healthcare systems are to continue to function long-term, we must address the importance of biosimilar monoclonal antibodies (MAbs) next. Science for MAbs is already here today and our industry is expecting a workable guideline,” he added.

Mr Perry praised the European Union (EU) for “continuing to inspire the rest of the world regarding the development of scientific biosimilar guidelines,” and pointed out that the aim of the 2004 EU pharmaceutical legislation was to introduce a legal basis for the approval of similar biological products designed to compete with existing reference products.

This year will see finalisation of the World Health Organisation (WHO) guidelines on the evaluation of similar biotherapeutic products; these are founded on the same basic scientific principles as in the EU and are “an important step towards a global, harmonised regulatory approach,” said Mr Perry.

The past year has also seen several milestone developments for the industry, with US Food and Drug Administration (FDA) approval of the first generic enoxaparin (Sanofi-aventis’ low molecular weight heparin Lovenox), a biosimilar filgrastim (Amgen’s granulocyte colony-stimulating factor [G-CSF] analog Neupogen) being placed on the substitution list in Norway and, in the UK in June, the National Institute for Health and Clinical Excellence (NICE) including a biosimilar product for the first time in its assessment procedure.

NICE included the use of Sandoz’ biosimilar Omnitrope (liquid somatropin for injection) as one of seven somatropin products which it recommended for use in the treatment of child growth deficiencies. In 2006, Omnitrope was the first biosimilar to be approved in the EU.

However, one major recent negative development has been the European Commission’s interpretation of the handling of duplicate marketing authorisations in the centralised procedure, as a result of which such applications are now not allowed for companies belonging to the same group. The issue needs to be tackled urgently, said Mr Perry, who added that it “constitutes a barrier to trade and will slow down the dynamic of market penetration of this new type of medicine.”

“For the sake of Europe’s patients, we need incentives on the demand-side, a consistent rational approach towards interchangeability and an increase of awareness and information aimed at reinforcing the confidence of patients and healthcare professionals in these high-quality biopharmaceuticals,” he said.

- Bringing a biosimilar to market takes up to eight years, with development costs averaging $100-$150 million. Last year, sales of biosimilars reached just $75 million worldwide compared with $110 billion in sales of biologic drugs; however, while turnover of biologics will reach $202 billion by 2013, $80 billion of this will be subject to competition from biosimilars, reports UK research firm Biophoenix. In 2013, it forecasts that biosimilars could generate a global market of $5.6 billion, or one-third of their potential market, assuming that they are priced at 70% of the innovator products and achieve a 30% share of units sold.