The Alliance for Safe Biologic Medicines was organized to serve as an authoritative resource center of information for the general public, as well as the healthcare and health policy communities, on the issues surrounding biologic medications.
Each state will be considering or introducing legislation to address what an FDA determination on interchangeability will mean for state substitution policies. While the ultimate goal is to find a balance between producing economical drugs and respecting the drug-discovery process, patient safety should be paramount.
We are particularly concerned about how state laws and regulations will impact the doctor-patient relationship. Doctors and patients should be able to carefully choose the best course of treatment rather than have legislators and regulators decide for them. The path state governments decide to pursue in approving biosimilars should reinforce this principle.
As such, a number of local organizations have joined together to ensure that state biosimilar interchangeability and substitution issues are not implemented in ways that negatively impact patient care or the role of the physician in that process.
Please check back for more information on our membership and activities.