INNsight articles by Peter Wittner, Interpharm Consultancy, July 09

At last something seems to be happening in the US in respect of Biosimilars or “Follow On Biologics” as Americans prefer to call them. While Europe has had a regulatory pathway for a while, the US still has no such mechanism in place and the whole topic has been the subject of lobbying from both sides with originators and generics companies pulling in opposite directions.

Various bills have been seeking approval from the Senate each with its own set of proposals regarding interchangeability and exclusivity. Exclusivity periods of 5, 7 or 14 years have been proposed depending on whether the backers favour the originators or the generics industry.

The Obama administration said in June that it favoured only seven years of market exclusivity, but in early July the US “Senate Health, Education, Labor and Pensions Committee” voted to provide biotech drugs with 12 years’ protection from generic competition. This is not the end of the story as nothing has yet passed into law, but this is a step forward.

What makes the market so attractive for generics companies is its size – forecasts suggest that Big Pharma have increasingly been shifting its product ranges towards biologicals for various reasons. A major reason is that they are more highly priced than simple chemical substances, but another is that they are much harder to copy. Of course, the companies themselves would justify this trend by pointing out that biologicals can be more effective than simpler substances and there is some truth in that too.

According to GPhA “the lung cancer drug Avastin costs about $100,000 per year; and the cost for Cerezyme, used to treat Gaucher disease, can run $300,000 or more per patient per year……… Estimates from various economic impact studies pin the projected savings from $42 billion on the low end to as high as $108 billion over the first 10 years of biogeneric market formation.”

Writing two years ago, I thought that there was at last some movement on setting up a regulatory mechanism in the US, but it did not happen. I offered the opinion that “Given the high financial and technical barriers to entry, the resultant market for Biosimilar products is likely to be characterised by a limited number of players, mainly the generic giants who can afford the high cost of entry. In addition, the limited number of players combined with high marketing costs means that there is not likely to be intense price competition – discounts will probably be limited to around 20 -25% off the original brand price.”

Launch prices for the biosimilars have been in that region in Europe where the big players who can afford to enter the market have take advantage of the clear EMEA guidelines to register and launch their biosimilars in way that is still not possible in the US.

This is a list of Biosimilars registered in Europe during 2008 through the EMEA’s Centralised Process including information about how long the authorities took to process the applications.

CHMP positive opinions in 2008 on similar biological medicinal products for human use: