Purple Is the New Orange - Webinar CD/Transcript
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;
- not similar
- highly similar
- highly similar with a fingerprint-like similarity
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:
- The 3 most important aspects of the Purple Book for manufacturers
- The do's and don’ts of using the Purple Book
- Tips and strategies for maximizing reimbursement by using the Purple Book
- Steps to ensure that you are utilizing the Purple Book correctly
- The relationship between the FDA's and state law requirements on interchangeability and substitutability of biologic products
- And much more …
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.