Biotechnology products have been the saving grace of the pharmaceutical industry for the last few years. As the industry has found itself in an innovation draught, biotech could be counted on to deliver novel new products. While still the case, it is becoming less so.
A few weeks back, IMS Health released its global biotechnology report. IMS noted that biotech sales were $75 billion in 2007, up 12.5% from 2006. BUT, this was the lowest level of sales growth in over a decade. Call it slowing. Call it a plateau. Call it the first cracks in the great biotech façade.
IMS agrees. “After 20 years of what some would call a ‘charmed life,’ biotech is now facing a new reality,” said IMS’ Murray Aitken. “Loss of exclusivity and competition from biosimilars, crowded therapy areas with weaker sales growth, payers showing more reluctance to fund innovative drugs without compelling value propositions, and safety concerns for some therapies will all contribute to a more moderate growth environment through 2012. Yet, we expect the biotech sector to remain one of the most robust segments of the marketplace with a continued strong flow of innovative products to the market.”
Against the backdrop of slowing biotech sales, a number of individuals are clamoring for imitation biotech products (without FDA oversight). Most recently, Dr. Geoffrey Allan, CEO of Insmed (a company trying to jump on the follow-on protein bandwagon), published an article in the Richmond Times-Dispatch calling for a regulatory pathway for imitation biologics. While I support the introduction of follow-on biological products, the complexity of the molecules requires proper oversight…AND FDA trials to ensure that the follow-on molecules are as safe and effective of the originals. There should be no AB rating for imitation biological products given the complexity of molecules.
This issue will continue to play out over the next few years, but will only put further downward pressure on biotech sales.
