Biogenerics

It was only a matter of time before the issue of generic biologics arose for the biotech industry - a matter of time about as long as the patent life of a biologic.

It is unfortunate that the issue has arisen in the context of a dispute between two companies in the sector, Amgen Inc. and Transkaryotic Therapies Inc., rather than as part of a reasoned discussion of the scientific and regulatory issues involved in creating generic biologics. Nevertheless, now that the question is before the industry, it makes sense to take a look at the technological and regulatory issues before rushing to judgement about political and business strategies that could have long-term and unforeseen effects on the entire sector...