This morning's biotechnology news seems to be full of surprise that the FDA has asked ImClone and BMS to provide additional data showing pharmacokinetic (PK) data that the ImClone and Merck KgA version of Erbitux are essentially equivalent.
One is approved in the US and the other in Europe.
In the recent studies for first line treatment in squamous cell head and neck cancer (SCCHN) and non-small cell lung cancer (NSCLC), the drug was supplied by their European partner, Merck KgA, even though it is not approved for use in the US. It would therefore seem reasonable to provide PK data demonstrating bioequivalence between the two versions of the drug, in the same way manufacturers must provide PK data when switching from a pill to a tablet form, for example. Or AstraZeneca's need for PK data when changing formulation during the clinical trials of Iressa. Different versions of a drug are often treated as different formulations by Health Authorities.
You can read more about it HERE (PDF download from ImClone).
Inevitably, it looks like the front-line approved of Erbitux in both NSCLC and head & neck cancer will be delayed while the companies sort out the bioequivalence studies.
Thanks to Richard Howell of IDBM Consulting for sending the Forbes article that stimulated this post.