Generics have been an attractive, lucrative development path for more than three decades. As the market has become saturated with simple generic products, biopharma companies are turning their focus to complex generic drugs, which deliver more value to patients by addressing additional unmet needs and which enable them to achieve market differentiation and opportunities for higher margins.
Developing complex generics in an era of rising costs and increased scrutiny over international development and manufacturing operations requires a higher level of expertise than is required for simple generics development. It demands a more sophisticated planning and development process, and a deep understanding of the regulatory, quality, and health technology assessment (HTA, pricing/reimbursement) environment to bring these drugs to market.
Generics developers who can adapt their clinical development to address these added challenges while still achieving speed to market can benefit from exclusivity and considerable return on investment. While cheaper than branded options, complex generics offer biopharma companies the opportunity to capture additional value commensurate with the associated additional risk and patient benefit.
“Complex Generics: Charting a New Path” is an IQVIA™ thought leadership report exploring the complex generics landscape and the challenges developers face bringing these drugs to market, and offers best practice advice for overcoming obstacles in order to benefit from this profitable shift in the marketplace.