Biopharma Firms: Overcome Roadblocks to European Expansion

Market expansion of innovative treatments can reduce health disparities and elevate the standard of care globally. It can also drive revenue and lifetime asset value. However, as pharmaceutical companies look to Europe while building out their launch and commercialization strategies, they must navigate complexities in regulations, language and culture, and pricing negotiations.

This Industry Outlook Report explores interdependent aspects of commercialization that differ significantly between the EU and the U.S. Adopting a global mindset long before launch can help bring life-changing treatments to more patients. Highlights include:

• How EU regulatory strategy and marketing authorization works, from centralized MA applications to national authorities for access and pricing.
• The EU pharmacovigilance model and what sponsors should do before submission.
• Navigating the health technology assessment process, which guides national level pricing and reimbursement decisions—and determines patient coverage.

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