Thought Leadership

The pharmaceutical industry has entered an era of change, during which product development will focus on niche patient groups; generics and biosimilars will fill the space vacated by patent-expired blockbuster drugs; and FDA will likely exhibit more regulatory authority for drug safety and use. This brief from PwC addresses the following.

• How REMS evolve with the changing pharmaceutical market
• Multiple sponsors
• Communication strategies
• Formalized decision making process
• Cost-sharing model