Developing complex generics to adapt to a challenging drug development process

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 a Quintiles 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.

What are complex generics?

The U.S. Food and Drug Administration (FDA) defines a generic drug as one that is identical – or bioequivalent – to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. 

  • A simple generic is a copy of a small molecule reference drug and is chemically identical to its branded counterpart.
  • A complex generic is a generic that could have a complex active ingredient, complex formulation, complex route of delivery, or complex drug device combinations.

Source: U.S. FDA

The European Medicines Agency (EMA) defines a generic drug as a medicine that is developed to be the same as a medicine that has already been authorised. It contains the same active substances and is used at the same doses to treat the same diseases as the reference drug.

EMA refers to complex generics as “hybrid medicines,” whose “authorisation depends partly on the results of tests on the reference medicine and partly on new data from clinical trials.”

Source: EMA

It is challenging, time-consuming and expensive to develop complex generics and demonstrate the equivalence, safety and efficacy of the therapy.