You are cordially invited to attend DIA's Biosimilars Conference, October 24-25, in Bethesda, MD.
FDA's final guidance on the naming of biologics (originator and biosimilar), issued this year, is in the implementation process and will have an impact on manufacturers, supply chain, end users, and safety systems. All stakeholders will need systematic approaches to ensure adherence – both prospectively and retrospectively.
How will these changes affect your systems and products? What will be your next steps?
Our conference brings you the most current science and regulatory developments for biosimilars, as well as the newest thinking and approaches on pharmacovigilance, prescriber and patient education, and access in the US, EU, Canada, and other regions.
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Conversations the Biosimilars Conference Will Spark |
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What new, state-of-the-art techniques can be used to identify and quantify molecular similarity and differences?
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What role do clinical studies play in biosimilar development?
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Biosimilars User Fee Act (BsUFA II): How will increased transparency, resource, and staffing changes at FDA expedite first-cycle approvals and the overall biosimilars development and approval process?
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Penetrating the US market: What barriers need to be broken down with prescribers and patients to realize the promise of biosimilars in reducing cost and improving access?
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Are you prepared to implement the FDA's Final Guidance on the naming of biologics? How will this impact manufacturers, supply chain, end users, and safety systems?
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What is the meaning of "Interchangeability?" Explore EU frameworks and the US FDA draft guidance for industry on considerations in demonstrating interchangeability with a reference product, highlighting data expectations, and relaying industry perspectives
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Complimentary Webinar: Moving Toward Clarity on Biosimilar Interchangeability
September 14 | 11:00AM-12:00PM ET
The term "interchangeable," when applied to biosimilars, has different meanings in different parts of the world. This webinar will provide a review of terminology, including differences in US and EU, definitions of interchangeability, and regulatory and legal frameworks as they relate to substitution of biologics. The US FDA draft guidance for industry on "Considerations in Demonstrating Interchangeability with a Reference Product" will be discussed, highlighting data expectations and noting remaining areas of uncertainty.
Presented by:
- Laura McKinley, Ph.D, Director, US Regulatory Policy Lead, Pfizer Essential Health, Pfizer, Inc
- Hillel Cohen, Ph.D, Executive Director, Scientific Affairs, Sandoz, Inc.
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