Manufacturing Chemist July, 2013
As the number of innovator pharmaceutical and generic manufacturer partnerships grow, the lines of responsibility for meeting pharmacovigilance requirements can get blurred. Chitra Lele, of Sciformix Corporation, looks at routes to managing the issue.
Among the multitude of challenges that face the global life science industry, the reduction in the number of new drug approvals has put tremendous pressure on innovator pharmaceutical companies. Despite the FDA announcing 39 new drug approvals in 2012 – a 16 year high – the past decade has been characterised by a severe innovation ‘drought’ that has seen the number of new medicines fall to little more than half previous levels.
In addition to this, competition from generic manufacturers has exploded due to an increase in patent expiries. It is estimated that generic competition eroded US$67bn from top drug companies’ annual sales in the US between 2007–2012, with more than three dozen drugs losing patent protection during this period.