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Biosimilars Action Plan (BAP)

Focus on four key areas

  • Improving efficiency of biosimilar and interchangeable product development and approval process
  • Maximizing scientific and regulatory clarity for biosimilar product development community;
  • Developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors
  • Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition

Actions will help create competitive market, provide incentives for sponsors

Commissioner Gottlieb’s remarksDynamic Regulation: Key to Maintaining Balance Between Biosimilars Innovation and Competition” at Brookings Institution about BAP

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CDER Conversation: Treatment for Opioid Use Disorder

Medication assisted treatment (MAT) is key to combating opioid use disorder (OUD)

  • Evidence-based, FDA approved medication (methadone, buprenorphine,  naltrexone) combined with counseling and psychosocial support
  • Decrease cravings,  relieve withdrawal symptoms; none cause euphoria or “high”

Use Information

  • Can be administered through different routes depending on specific drug; however,  many clinicians are not assessing and treating patients with OUD
  • Potential for drug-drug interactions
  • Recommended for pregnant women with substance use disorder
  • SAMHSA’s treatment locator service can be helpful in finding a nearby treatment program

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CaptureProtecting and Promoting Public Health: Advancing the FDA’s Medical Countermeasures Mission 

Role in national security by facilitating development and availability of safe and effective medical countermeasures

  • Animal Rule: Efficacy data obtained solely from animals when studies in humans are not ethical or feasible
  • New guidances: eg smallpox
  • Emergency Use Authorizations: Facilitating availability and use of MCMs needed during public health emergencies
  • FDA and DoD joint program for development of medical oroducts intended to save  American military personnel
  • FDA’s Medical Countermeasures Initiative (MCMi) established in 2010

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New efforts to empower consumers by advancing access to nonprescription drugs

Increase access to broader selection of nonprescription drug products  empowering consumers to self-treat common conditions and potentially some chronic conditions

  • lower costs for health care system overall
  • provide greater efficiency and empowerment for consumers
  •  access to resources to help patients determine if medicine is right for them

Use of innovative technologies

  • Mobile Medical App with a set of questions to help someone determine (self-select) appropriateness of drug for them
  • Sponsors could develop approaches for self-selection and accurate use of their prescription product in the nonprescription setting

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CaptureAgency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

Encouraging development of opioids with abuse-deterrent formulations (ADFs) intended to make certain types of abuse, e.g. crushing, dissolving, more difficult or less rewarding

  • New 43 product-specific guidances related to the development of generic drug products
  • In vivo and in vitro study considerations for abuse deterrence evaluations
  • Final guidance  on development of generic versions of approved ADF opioids

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Image credits: FDA

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