Skip navigation

Best Practices and Breakthrough Strategies for High-Value Opportunity

March 26-27, 2019
  • Philadelphia, PA
Overcome Development Challenges to Achieve a Successful and Efficient Complex Generic Drug

As drug pricing scrutiny is on the rise and 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 providing more affordable drug options, enabling 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.

CBI’s Complex Generics conference explores 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 the high-value opportunity borne from this shift in the marketplace.

Top Conversations Include:

  • Regulatory and policy considerations for complex generics
  • Scientific considerations for establishing bioequivalence for varied complex generic delivery methods
  • Specific product quality challenges in developing different approaches to complex generic product manufacturing to meet sameness in product performance and cGMP requirements
  • Opportunities to improve communication and collaboration between industry, academia and the FDA in developing innovative methods and standards for assessing the sameness of complex generic products

Complex Generics

Best Practices and Breakthrough Strategies for High-Value Opportunity

Overcome Development Challenges to Achieve a Successful and Efficient Complex Generic Drug

As drug pricing scrutiny is on the rise and 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 providing more affordable drug options, enabling 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.

CBI’s Complex Generics conference explores 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 the high-value opportunity borne from this shift in the marketplace.

Top Conversations Include:

  • Regulatory and policy considerations for complex generics
  • Scientific considerations for establishing bioequivalence for varied complex generic delivery methods
  • Specific product quality challenges in developing different approaches to complex generic product manufacturing to meet sameness in product performance and cGMP requirements
  • Opportunities to improve communication and collaboration between industry, academia and the FDA in developing innovative methods and standards for assessing the sameness of complex generic products