FDAnews
Falls Church, VA (PRWEB) October 27, 2014
Purple Is the New Orange:
Why Drugmakers Must Understand the FDA’s New Purple Book on Biosimilars
**FDAnews Webinar**
Nov. 12, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/PurpleTheNewOrange
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
- 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. To address these questions, FDAnews has scheduled a 90-minute webinar on Tuesday, Nov. 18, that will give attendees a detailed overview of the Purple Book and what the FDA expects from manufacturers in using it.
Attend and 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 attendees understand the new Purple Book.
Attendees will 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 the Purple Book is being utilized correctly
- The relationship between the FDA's and state law requirements on interchangeability and substitutability of biologic products
- And much more …
Drugmakers 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.
Get a full update on the new Purple Book for biologics.
Meet the 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.
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.
Who Will Benefit:
- Clinical project specialists
- Clinical research associates
- Compliance officers
- Pharmaceutical and cGMP auditors
- R&D staff
- Regulatory/legislative affairs professionals
- Healthcare providers
- Pharmacy providers
- Drug companies
- Biotech companies
- Biologic companies
- Regulatory agents
Webinar Details:
Purple Is the New Orange:
Why Drugmakers Must Understand the FDA’s New Purple Book on Biosimilars
**FDAnews Webinar**
Nov. 12, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/PurpleTheNewOrange
Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts
Easy Ways to Register:
Online: http://www.fdanews.com/PurpleTheNewOrange
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.