Biosimilars Business Review, April 2008

Europe saw another positive move in February 2008, when the EMEA recommended approval for three GCSF biosimilars. Marketing can begin once the European Commission issues final approval in April 2008. This will mark Teva’s first biosimilar approval in the EU; the company is developing its biosimilar activities apace, as demonstrated by the recently-announced purchase of CoGenesys.

An indication of attitudes to biosimilars in the European marketplace was given by the publication of a report by a UK parliamentary panel into the subject in January. It indicated a general lack of awareness of biosimilars within the Department of Health and the wider health service, and came down strongly against the allowance of substitution. Shortly afterwards, the MHRA issued a brief guidance stating that it is ‘good practice’ to prescribe by brand name only. The parliamentary panel issued a number of other recommendations, none of which will be particularly welcome to the biosimilar industry.

In the USA, the wind has changed, for the time being at least. The running is now being made by the originator industry, which has decided its best interests are served by passing legislation this year rather than delaying; the political environment may be less favourable in 2009. Hence the specific mention of biosimilar regulations in President Bush’s budget request, and the public support given by BIO to the new Barton-Eshoo bill in the House. In contrast, the biosimilar industry has become more cautious, calculating that it can get a better bill after the November 2008 elections. With Congress finely balanced and a real lack of consensus over the issue of market exclusivity, it would be brave indeed to predict the creation of a pathway this year.

Andrew Crofts – Editor, Biosimilars Business Review