Notifications and Names: FTC Workshop Explores Effect of State Legislation and Naming Conventions on Follow-On Biologic Competition

Biologic medicines represent some of the most significant—both clinically and financially— pharmaceutical products in the United States today. Biologics have had remarkable success in the treatment of patients with many common diseases and disorders such as cancer, diabetes, multiple sclerosis, arthritis, and anemia. However, biologics remain one of the most expensive categories of medicines on the market. According to the Federal Trade Commission (“FTC”), the cost of one year of treatment of a biologic medicine can range from $50,000 to $250,000.

Biologics’ active drug substances are cultivated from living organisms by means of recombinant DNA or controlled gene expression methods. Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics are “typically larger and more structurally complex molecules” than the traditional small molecule drugs. Therefore, production of biologics requires more difficult and expensive manufacturing processes and techniques to ensure consistency.

Please see full article below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Wilson Sonsini Goodrich & Rosati | Attorney Advertising

Written by:


Wilson Sonsini Goodrich & Rosati on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.