The Food and Drug Administration (FDA) has proposed new naming policies for the distinct naming of biosimilars and biologics for rheumatoid arthritis treatment. The new draft guidance is called Nonproprietary Naming of Biological Products: Guidance for Industry and is available to view here.
Under the new policies, which will be designated and enforced by the FDA, separate and distinctive names will be required when it comes to biosimilars and biologic drugs. This will ensure that pharmaceutical companies are following regulations and will remain compliant when it comes to the naming and marketing of biosimilar medications.
The new policies came as a result of letters of concern written by the American College of Rheumatology (ACR) to the FDA. The letters called for transparency and patient safety and addressed patients’ concern that biosimilars could be substituted for biologics without the consent or knowledge of patients.
In a statement issued by the ACR, Dr. Doug White, the chairman of the ACR’s Committee for Rheumatologic Care, said: “The ACR commends the FDA’s proposal to require distinctive names for biosimilar drugs and original biologics. Distinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved – pharmacists, providers, and patients – which drug the patient is receiving.”
“The FDA’s proposal to require distinguishable names for biosimilars will help rheumatologists and other specialists ensure patients continue to receive breakthrough therapies that are both clinically appropriate and effective without compromising their health or safety,” White adds.
The FDA defines biosimilar as “a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.”
In Canada, Health Canada uses the term “subsequent entry biologics (SEBs)”. The infographic here, courtesy of Arthritis Consumer Experts, is a summary of what SEBs are and what Health Canada’s position on SEBs is. Please click here to learn more about SEBs.
In the long term, SEBs will have an increasing role to play in the Canadian health system. What we don’t know is how will SEBs perform once in wide use in Canadian patients compared to their originator biologics. Want to be involved?
- Stay informed and seek out “lay language”, research-based information about SEBs
- Continue to share perspectives and experiences around this important health topic
- Help educate your friends, family and community – they will be affected by the arrival of SEBs
- Understand how SEBs are assessed and listed on public and private formularies