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As the number of innovator pharmaceutical and generic manufacturer partnerships grow, the lines of responsibility for meeting pharmacovigilance requirements can get blurred. This whitepaper 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 approving 39 new drugs in 2012, a 16 year high, only 27 drugs were approved in 2013. The past decade has been characterized 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 $67 B from top drug companies’ annual sales in the US between 2007–2012, with more than three dozen drugs losing patent protection during this period.
Download and learn:
- Imperatives to consider when adopting a model for PV outsourcing due to global expansion
- Big pharma/generics partnerships
- Managing pharmacovigilance
- Defining the roadmap: a case study
- Critical success factors