Europe gets nervous over biosimilar rules

The United Kingdom is currently debating new biosimilar rules, as part of a movement amongst European countries to limit how centralised biosimilar approvals are prescribed. Recommendations put forward include prescription of biosimilars by brand names only, an urgent ban on substitution "until effective safeguards can be relied on", and applying the Medicine and Healthcare Regulatory Authority’s black triangle symbol "be applied to all biosimilar drugs and that, at two-year or other periodic review, that symbol should remain unless the safety evidence is clear that it can be removed".

Changes to prescription rules follow advice from the EMEA in June 2007 that biosimilars cannot be considered identical to their biological reference products. However, while the agency can issue advice, prescription policies are set at a national level; this has led to European countries diluting the strength of the original centralised rules, mainly due to safety fears caused by biosimilar complexity and subtle differences from originator products. According to the European Generic medicines Association (EGA), fifteen countries across Europe have brought in new rules to prevent the automatic substitution of biological medicines by biosimilars, including France, Spain, the Netherlands and Norway.

This contrasts with the approach in the United States, which has not even got so far as creating a biosimilar pathway. However, events in Europe are an indication that the US may also run into difficulties with biosimilar prescription rules following the approval of its own biosimilar legislation. This itself is currently on hold, as a suitable compromise between originator and biosimilar firms has not yet been reached. Interestingly, the forces pushing for legislation sooner have recently been reversed, with the branded industry keen to get a bill through Congress before President Bush leaves office.

The US and European biosimilar agendas are notably different at present, united only by lingering uncertainties remaining in both. This is likely to remain the case in the short term, due to a number of factors such as safety fears and the high costs of producing biological drugs in any form. The boom year for the biosimilar industry will not arrive until 2012 at the earliest, when a much higher proportion of biological drugs start to come off patent. At that time, the financial incentives of promoting biosimilars will be hard for governments to ignore, while experience of biosimilars should lead to more uniformity in safety rules.

Jonathan Way - Editor, World Generic Markets