PART 1: #12215
This initial webinar will introduce biosimilars and describe
the content of the Questions & Answers and present the components of the
Scientific Concepts document. The presenters will suggest approaches that might
be useful in satisfying the respective areas of the guidance: legal/regulatory,
preclinical and clinical components of a biosimilar program. Focus will be on:
explaining the actual document, considering ways that the guidance may be
satisfied and possible alternatives to the suggested approach.
Links to the Biosimilar Draft Guidances that Part 1 will
address:
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
- Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act 2009
PART 2: #12216
This webinar will focus on Quality Considerations in
Demonstrating Biosimilarity to a Reference Protein Product. The guidance lists
principles and factors that should be considered and these will be discussed.
Some in vitro comparisons that will be useful in demonstrating similarity
between a biosimilar product and its approved reference will be discussed in the
context of the guidance.
Link to the Biosimilar Draft Guidance that Part 2 will
address:
http://www.marketwatch.com/story/bio-testifies-on-importance-of-timely-passage-of-bsufa-and-pdufa-2012-03-29
ReplyDeleteBIO Testifies on Importance of Timely Passage of BsUFA and PDUFA
Offers support for sufficient appropriations for FDA
WASHINGTON, Mar 29, 2012 (BUSINESS WIRE) -- Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization (BIO), testified today on biosimilar user fees (BsUFA) and the Prescription Drug User Fee Act (PDUFA) before the Senate Health, Education, Labor and Pensions Committee in a hearing entitled, “FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients.”
In her testimony, Radcliffe expressed support for the establishment of a biosimilars user fee program as part of the Food and Drug Administration’s (FDA) implementation of a well-constructed, science-based pathway for the approval of biosimilar products that protects patient safety and preserves incentives for innovative new therapies.
http://www.insidecounsel.com/2012/03/27/fda-releases-biosimilars-draft-guidances
ReplyDeleteFrom the April 2012 issue of InsideCounsel Magazine • Subscribe!
FDA releases biosimilars draft guidances
Documents are first step in expedited pathway for generic biotech drugs
By Melissa Maleske
March 27, 2012 • Reprints
In the small-molecule drug area, which covers chemical drugs, the Food & Drug Administration (FDA) has provided generic drug makers with an expedited approval process—and incentives for companies to take advantage of them—since the 1984 Hatch-Waxman Act. The pathway changed the market, creating a generic drug industry that in 2011 accounted for more than 70 percent of all prescriptions in the U.S., according to IMS Health, a pharmaceutical intelligence company.
Hatch-Waxman didn’t cover the $30 billion biological products market, however. Biologics are drugs and treatments that are far more complex than small-molecule drugs. They require much more complicated manufacturing processes and often are derived from living cells or tissues. The most widely used biologics treat diabetes, cancer, rheumatoid arthritis and multiple sclerosis. When a drug has no clinically meaningful difference from a reference product, it is biosimilar.