As patients we need to know what drugs we are taking. With our doctors, many of us have spent years finding the right treatment regimen. We must urge the FDA to ensure distinct labeling to guarantee the safe and transparent introduction of biosimilars. CreakyJoints works to improve the quality of life for people living with chronic disease by making sure our voices are heard. We need you to lend your voice to a time-sensitive issue around the safety of our medications. Many of us greatly benefit from the use of biologics (such as Enbrel and Humira - two of the most commonly prescribed biologics). And now we are hopeful about the introduction of biosimilars which promise to positively change the treatment landscape.
Biosimilars have similar active properties as biologics. They have the potential to dramatically reduce the cost of biologic drugs and increase access to life-saving medications. Yet,
biosimilars are not identical to biologics and their labeling should not be either. We believe the FDA should require labeling that:
- Reflects the key clinical data used in its approval by the FDA
- Clarifies whether or not the FDA has determined the biosimilar in question is interchangeable with the biologic
- Notes which approved indications are based on extrapolation of the biologic clinical trials data.
