The Food and Drug Administration recently approved the first in a new category of biologic drugs known as “biosimilars,” and soon will consider approval of others. Although biosimilars have great potential for improving patient access to life-saving biologic medicines, congressional oversight is needed to ensure patient safety guides the biosimilar approval process at the FDA.
Biologic medicines are made from living organisms and are far more complex and difficult to develop than traditional chemical drugs. The advent of biologic medicines has saved and transformed the lives of Americans who have been diagnosed with many serious and life-threatening conditions.
For individuals living with spinal cord injury and/or disease, access to biologic treatments is necessary to control symptoms and relieve pain. The potential arrival of biosimilars to the market brings promise of new therapies to our community but also carries potential risk.
The Biologics Price Competition and Innovation Act, signed into law in 2010, established new regulatory authority for the FDA to review and approve biosimilars. Biosimilars are medicines that are highly similar, but not identical, to innovative biologic medicines. Under this new law, the agency recently approved the first biosimilar in the United States.
The FDA has accepted the five applications for approval of biosimilars and more applications are expected to come in the next few months. Even with the potentially imminent approval of additional biosimilars, the FDA has yet to issue final guidance on critical consumer safety issues, including what the new drugs will be called, what will be on their label, whether they will be considered interchangeable with the biologics on which they are based and whether these new drugs should be tested for every condition they hope to treat.
Congressional oversight is critical to making sure individuals will not be at risk. To date, there have been no congressional hearings on biosimilars, even as the FDA creates the pathway for the approval of biosimilars.
United Spinal Association and other consumer advocacy groups have met with the FDA to help ensure consumer safety is paramount and that the FDA makes good policy from the outset when it comes to biosimilars. FDA guidance on remaining safety issues and a review and comment period will be critical to establishing consumer and prescriber confidence in this new class of drug. A one-size-fits-all approach to approving biosimilars is unacceptable.
United Spinal believes that all products, including biosimilars, should carry non-proprietary, distinguishable names to facilitate accurate and prompt identification in case of an adverse event. The label for biosimilars should include a distinct name as well as indicate that it is a biosimilar and not the innovator biologic. Consumers living with different disabilities and chronic illnesses and their physicians should not be confused about what medications they are taking.
BPCIA authorized the FDA to provide a stringent standard for interchangeability, which requires a significantly higher standard for approval as well as ensuring the biosimilar achieves the same clinical result in any given patient. The agency has yet to release this guidance and within the limitations of current science, it is impossible to make exact copies of biologics. Therefore, differences between biosimilars and biologics, even if they are subtle, create uncertainty and could impact patient health.
In addition, particular attention must be given to ensure that rigorous clinical testing proves that a biosimilar is effective and safe in each and every condition or disease which it is approved to be prescribed, as well as in each distinct group of individuals with that disease. Our members have the right to live fully functional lives, including full participation in society with effective and safe healthcare interventions so that they can participate in school, go to work, have families. Be they young, old, living with a spinal cord injury or a disabled veteran, it is worth it for our members and our society to ensure that the FDA does what is right.
We urge Congress to schedule BPCIA oversight hearings to ensure the voice of our members and the broader disability community is heard as the FDA approves biosimilars.
James Weisman is the executive vice president and general counsel of United Spinal Association.