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Best Practices and Breakthrough Strategies for High-Value Opportunity

March 26-27, 2019
  • Philadelphia, PA

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 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.

Overcome Development and Commercial Challenges to Achieve
a Successful and Efficient Complex Generic Drug Product (CGDP)

  • Explore the growth of the complex generics market in an era of rising costs and increased scrutiny over international development
  • Navigate the influx of new FDA guidance documents relevant to
    the development of complex generics
  • Examine the regulatory and policy considerations for complex generics
  • Address scientific considerations for establishing bioequivalence for varied complex generic delivery methods
  • Overcome specific product quality challenges in developing different approaches to complex generic product manufacturing to meet sameness in product performance and cGMP requirements
  • Identify opportunities to improve communication and collaboration between industry, academia and the FDA in developing innovative methods and standards
  • Assess the nuances related to the commercialization of CGDPs and uncover opportunities for global development of complex generics

HOT IN THE NEWS:

Being able to ‘genericize’ a complex drug can be a high-value opportunity for a generic drug maker that helps underwrite the costs of other generic applications. In other words, because brand-name versions of complex drug products are often higher-priced than many other brand name drugs, any steps we can take to encourage the development of generic competitors to complex drugs will have an outsized impact on access, and prices.

FDA Commissioner, October 2, 2017

On the R&D front, companies are rationalizing their spending by dropping plain vanilla generics development where there are already several Abbreviated New Drug Application (ANDA) filers awaiting approval or existing competition is high. They are instead focusing their spend towards complex generics, specialty products including NCEs (New Chemical Entities) & NTEs (New Therapeutic Entities) and bio-similars where less competition is expected. Players are progressively focusing on developing value-added generics (NTEs) by combining drugs, new route of administration or dosage form which allows them certain exclusivity and at the same time the risk reward ratio is more favorable.

Biospectrum India, November 28, 2018

In October 2018, FDA announced that it had approved – and tentatively approved – more generic drugs in fiscal year (FY) 2018 than in any other year prior. FY 2018 saw a total of 971 approvals, 781 final approvals and 190 tentative approvals, a number just higher than the 937 total in FY 2017… Of the 971 approvals, roughly 12% were for complex generics – like EpiPens – while 95 first generic drugs were approved.

PolicyMed, December 2, 2018

Complex Generics

Best Practices and Breakthrough Strategies for High-Value Opportunity

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 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.

Overcome Development and Commercial Challenges to Achieve
a Successful and Efficient Complex Generic Drug Product (CGDP)

  • Explore the growth of the complex generics market in an era of rising costs and increased scrutiny over international development
  • Navigate the influx of new FDA guidance documents relevant to
    the development of complex generics
  • Examine the regulatory and policy considerations for complex generics
  • Address scientific considerations for establishing bioequivalence for varied complex generic delivery methods
  • Overcome specific product quality challenges in developing different approaches to complex generic product manufacturing to meet sameness in product performance and cGMP requirements
  • Identify opportunities to improve communication and collaboration between industry, academia and the FDA in developing innovative methods and standards
  • Assess the nuances related to the commercialization of CGDPs and uncover opportunities for global development of complex generics

HOT IN THE NEWS:

Being able to ‘genericize’ a complex drug can be a high-value opportunity for a generic drug maker that helps underwrite the costs of other generic applications. In other words, because brand-name versions of complex drug products are often higher-priced than many other brand name drugs, any steps we can take to encourage the development of generic competitors to complex drugs will have an outsized impact on access, and prices.

FDA Commissioner, October 2, 2017

On the R&D front, companies are rationalizing their spending by dropping plain vanilla generics development where there are already several Abbreviated New Drug Application (ANDA) filers awaiting approval or existing competition is high. They are instead focusing their spend towards complex generics, specialty products including NCEs (New Chemical Entities) & NTEs (New Therapeutic Entities) and bio-similars where less competition is expected. Players are progressively focusing on developing value-added generics (NTEs) by combining drugs, new route of administration or dosage form which allows them certain exclusivity and at the same time the risk reward ratio is more favorable.

Biospectrum India, November 28, 2018

In October 2018, FDA announced that it had approved – and tentatively approved – more generic drugs in fiscal year (FY) 2018 than in any other year prior. FY 2018 saw a total of 971 approvals, 781 final approvals and 190 tentative approvals, a number just higher than the 937 total in FY 2017… Of the 971 approvals, roughly 12% were for complex generics – like EpiPens – while 95 first generic drugs were approved.

PolicyMed, December 2, 2018