miércoles, 23 de mayo de 2018

FDA releases new video series to provide an overview of biosimilar and interchangeable products - Drug Information Update

FDA is announcing our new five-part video series, designed to provide an overview of biosimilar and interchangeable products and to highlight key concepts about the development and approval of these products, as well as how state-of-the-art technologies and tools are used to demonstrate biosimilarity. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved reference product. To date, the FDA has approved ten biosimilars, which may  help create more market competition and patient access to therapeutic biological products—many of these biosimilars treat serious and life-threatening illnesses.

The number of FDA-approved biosimilar products continues to grow. We want health care professionals, patients, and other stakeholders to understand what these products are and the rigorous standards that biosimilars must meet before the FDA can approve them.

The video series is part of a larger education and outreach effort about biosimilar and interchangeable products:
  • The Promise – provides information about these new treatment options, greater access to life saving medications, and cost competition
  • The Basics – introduces key terms and concepts about biosimilars, and discussed why patients and healthcare professionals should be confident in these products
  • Interchangeability – describes interchangeable products and reviews the requirements that are needed to meet this standard
  • The Development – delves into more about the abbreviated licensure pathway and the stepwise approach to demonstrating biosimilarity
  • The Data – explains how analytics are used in the biosimilar development and approval process
Visit the biosimilar web page to see other materials such as fact sheets, shareable graphics, and other resources.

The FDA will continue to play a prominent role in facilitating the efficient development and approval of high quality, safe and effective biosimilar and interchangeable products.  Greater availability of biosimilars can increase access to important treatments and competition in the marketplace of biological products, which in turn can help bring down the costs of these products to patients

FDA offers a variety of patient and prescriber outreach materials, including graphics, drop-in content, and social media messages, to help promote understanding of biosimilars and interchangeable products.
This video presents the benefits of biosimilars, featuring FDA Commissioner Scott Gottlieb, M.D., and Director of OND Therapeutic Biologics and Biosimilars Staff, Leah Christl, Ph.D.
Thumbnail of The Promise of Biosimilars video
This video provides an overview of biosimilars and the FDA approval process, featuring Leah Christl, Ph.D., Director of OND Therapeutic Biologics and Biosimilars Staff at FDA CDER.
Thumbnail of The Basics of Biosimilars video
This video explains the interchangeability of biosimilar products and FDA’s rigorous research and evaluation, featuring Leah Christl, Ph.D., Director of OND Therapeutic Biologics and Biosimilars Staff at FDA CDER.
Thumbnail of The Concept of Interchangeability video
This video outlines FDA’s abbreviated licensure pathway for biosimilars, featuring Sue Lim, M.D., Director of the Scientific Staff, OND Therapeutic Biologics and Biosimilars Staff at FDA CDER.
Thumbnail of The Biosimilar Development Process video
This video describes the data, studies, and analytical tools required to demonstrate biosimilarity, featuring Steve Kozlowski, M.D., Director of the Office of Biotechnology Products at OPQ, FDA CDER.
Thumbnail of Analytical Data for Biosimilars video
Fact Sheets
Biological Product Definitions (PDF – 230 KB)
Learn more about biologics, biosimilars, interchangeable products, and other related terms.

Biosimilar Product Regulatory Review and Approval (PDF – 206 KB)
Learn more about the development, review, and approval processes for biologics.

Prescribing Biosimilar Products (PDF – 187 KB)
Learn more about the prescribing of biosimilar products.

Prescribing Interchangeable Products (PDF – 166 KB)
Learn more about the prescribing of interchangeable products.
Biosimilar Development Process (PDF - 382 KB)
This infographic explains the totality of the evidence approach used in determining biosimilarity.
Biosimilar Development Process
What Is a Biosimilar? (PDF - 220 KB)
This infographic introduces key concepts related to biosimilars, including an introduction to biologics, what “highly similar” means, what “no clinically meaningful differences” means, and how biosimilars are evaluated and monitored.
Stakeholder Toolkit
The following information is provided to help you promote FDA as a resource for information on biosimilars and interchangeable products and encourage prescribers and patients to talk to each other about these medications.

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