By James Weisman
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.
