The Congruence Between Small Molecule Generic Medicine and Biosimilar Medicine Business Models

摘要

The generic medicine industry has generated significant cost savings for payers over many years (over 100 billion euros in Europe alone in 2014) and provided access to affordable medicines for millions of patients. Competition has been generated through the availability of generic medicines from multiple sources delivering lower prices and a choice of suppliers. One aspect of such competition is that in order to maintain growth a generic portfolio has to be replenished or refreshed frequently. Many generic companies set targets of 20 new products to be launched each year. Product development of new generic molecules starts early in the life cycle of the originator product so long term planning is essential and mainly based on product patent expiries. Following the patent cliff in 2012 it became apparent that the opportunities for developing a new range of 'blockbuster' generic medicines based on small molecules would be curtailed, such molecules diminishing in numbers in the ensuing 5-10 years. The opportunities for growth from the existing portfolio of legacy products was also being constrained by the slow, or even declining, growth of traditional therapy areas where generic medicines dominated. In Europe, analysis showed the challenge facing manufacturers of declining prices and low volume growth.