FDA Establishes Biosmilar Naming Convention

Last week, FDA announced the highly anticipated guidance, along with a proposed rule, which will establish a naming convention for biological products, including both related and biosimilar products. FDA states that a “shared proprietary names are not appropriate for all biological products.” In addition, the Agency says that, for both pharmacovigilance and safe use purposes, there is a large need to clearly identify different biological products that have not been identified as interchangeable.

According to FDA’s plan, both branded and biosimilar products will share what they call a “core drug substance” name. In addition, each product will also have a suffix that will be made up of four letters. The suffixes will not be derived from the manufacturers name and will be individualized from product to product.

FDA is asking for feedback from industry professionals on their new guidance and proposed rule. Comments are currently being submitted here, and are being accepted until October 27, 2015 on the guidance, and until November 12, 2015 on the rule.

For the last 35 years, we have been helping our clients achieve successful interactions with the FDA and have established a strong relationship with the Agency over the years.  We have the knowledge and experience you need to develop and submit a successful application.  Contact us today to learn more about our services and how we can help you.