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Purple Is the New Orange: Why Drugmakers Must Understand the FDA’s New Purple Book on Biosimilars
For the first time ever, FDA has published a new list of licensed biological products and interchangeable biosimilars. Hyped as being the biological equivalent of the pharmaceutical “Orange Book”, the all new “Purple Book” will seek to answer questions about the interchangeability of products.
Due to manufacturing differences, biosimilar products are not exactly the same as the products they aim to replicate, which causes concern about how companies will be able to illustrate interchangeability without extensive testing.
Similar to FDA's Orange Book assessments for chemical drugs, the Purple Book will introduce FDA’s a four-part categorization assessment for interchangeability;
Whether FDA will maintain a range of "interchangeable" rankings, similar to the way drugs are graded in the Orange Book, is yet to be seen, but some questions can be answered now. The webinar CD and transcript will give you a detailed overview of the Purple Book and what the FDA expects from you in using it.
You’ll hear from attorneys and pharmaceutical and healthcare regulation experts, Lee Rosebush and Nita Garg, from Baker & Hostetler LLP, Washington, D.C. Lee and Nita will apply their extensive experience with and knowledge of the Orange Book to help you understand the new Purple Book.
You’ll come away knowing:
Drugmakers like you have waited patiently as the FDA has methodically developed regulations and guidances for biosimilar approval. Now, with release of the Purple Book, the time has finally come to move forward with your plans.
Get a full update on the new Purple Book for biologics — and what it means for you.
Meet Your Presenters
Lee Rosebush is Counsel with Baker & Hostetler LLP in their Washington, D.C. office. With a background as a defense, regulatory, and registered patent attorney who has also worked as a registered pharmacist, Lee Rosebush provides his clients with legal counsel that is grounded in first-hand experience.
Whether his clients are confronted with legal issues related to the naming of a drug, clinical trials, marketing, promotions, or advertising, Lee possesses a strong understanding of the pharmaceutical industry which, combined with his attention to detail and experience working with biologics, medical device, and healthcare companies, gives clients a single source for regulatory and litigation counsel.
Nita Garg an Associate with Baker & Hostetler LLP in their Washington, D.C. office. She focuses her practice on healthcare regulation and litigation, and assists clients with healthcare issues, including those related to fraud and abuse, HIPAA, and employment agreements.
With a background that includes work in the legal services department of a hospital and the Civil Medicaid Fraud Unit at the Office of the Attorney General of Texas, Nita has a depth of knowledge regarding the inner functions of the healthcare industry that aids in her understanding of her clients' needs.
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