Biosimilars Naming and Labeling: An FDLI Dialogue

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During this half-day program, thought leaders and industry experts will engage in an open and balanced dialogue—with audience participation—on biosimilars naming and labeling issues. Exploring issues that have not yet been addressed publicly by FDA, this discussion will, for example, address whether and how to identify a reference biologic and its biosimilar through naming and in labeling. We will ask “what’s in a name” and how many goals a nonproprietary name should satisfy. We will discuss what studies should be included in a biosimilar biological product’s package insert and whether FDA can or should address substitution practices and interchangeability questions through labeling. The November 16 Dialogue will be equally important to companies developing innovative biologics and companies developing biosimilars, and should be valuable for professionals with regulatory, scientific, or legal perspectives. FDLI invites all attendees to join the conversation.


Event Details:

When: Wednesday November 16 2011, 8:30 AM – 12:30 PM
Where: Morgan Lewis, 1111 Pennsylvania Avenue, NW, Washington, DC, 20004, United States
Cost: $ 395 Member $ 445 Partner, BayBio Members $ 495 Non-Member $ 295 Government and Academic Member $ 395 Government Academic Non-Member $ 125 Student Member $ 150 Student Non-Member


San Francisco Cluster Snapshot

The San Francisco life science cluster is one of the major hubs helping to define the entire Northern California region. Overall, Northern California employs a whopping 90,000 people across roughly 1400 medical device, biotech and pharmaceutical companies.