EU biosimilars regulations still need 'clarifications'
for biosimilars that still need to be clarified, a panel of
industry experts said during BIO 2007.
Speakers at a discussion on the European approach on biosimilars addressed the challenges of the approval scheme implemented by the European Medicines Agency (EMEA), which distinguishes between biosimilars (follow-on biologics) and standard generic drugs. According to Thomas Bols, Amgen's director of government affairs in Europe, there are still some issues that need to be tackled as the stage is set for the entry of more biosimilars into the European market. "We expect to see a number of biosimilars entering the market in the next few years, however, they are still some challenges," he said. He pinpointed four areas in particular need of clarification, including the issue of substitution of a biosimilar for an innovator product. However, the substitution issue is for national health authorities to deal with, said Georgette Lalis, a director in the European Commission's Directorate General of Enterprises and Industry. Bols also cited the safety issues or 'pharmacovigilance' of biosimilars as a hurdle to overcome, as well as the issue surrounding the generic names of biosimilars and their labelling. Under the current World Health Organisation's (WHO) drug naming system, each therapeutic coumpound is assigned an international non-proprietary name (INN) so that each would be recognised globally by a unique name, facilitating the identification of pharmaceutical substances and active pharmaceutical ingredients. In addition, INNs are also assigned to bioligics, which are more difficult to deal with due to their complexity, according to the WHO. As a result, the WHO last November said it was time to update the INN system and adapt its nomenclature for biologicals to reflect how science has evolved during the last five years, in particular with the arrival of biosimilars in the pharmaceutical landscape. "Biosimilars are not identical to the original products and therefore need a distinct naming system," said Bols, adding there was a need to ensure European pharmacovigilance systems could cope with the changes. Ajaz Hussain, vice president of biopharmaceutical development at Sandoz, the company who launched the first biosimilar in Europe last year, said there was a need to realise there was an opportunity for a "win-win" situation opportunity to fulfil patients' needs. Sandoz's Omnitrope was approved in Europe in April 2006 by the European Commission. "The key is to have a strong intellectual property (IP) protection. After expiration of patents there should be unhindered competition to ensure greater access to affordable medecines," said Hussain. He added there was a need for scientific assessment of interchangeability. Also speaking at BIO in Boston last week, John Purves, head of sector at the EMEA, also said that not only the INN issue, but also a harmonisation of the regulatory system and a better communication to stakeholders, were some of the challenges for the future at the EMEA. "We have had a constructive introduction of biosimilars and some positive feedback, and our goal is to update the guidelines in the future," he said.
