Biologic drugs can treat a variety of illnesses—including cancer and certain types of arthritis—imore effectively than traditional, chemical based products. For this reason, the medical community is excited about the potential of these so called “miracle drugs.”
Of course, many manufacturers have attempted imitate biologic innovator drugs, but unlike chemical drugs which are easy to replicate, biologics are complex organisms and cannot be copied exactly. This means the imitator drug cannot be identical to the innovator and therefore poses a potential danger to patients.
A dependable approval process must be established in order to ensure that no patients are unnecessarily harmed by biosimilar drugs. Congress recently responded to this need by including a provision in the Affordable Care Act directing the FDA to establish an approval pathway for biosimilar drugs. These efforts are already underway and the agency recently held a meeting in which various entities offered their thoughts on the pathway’s creation.
One interesting model the FDA could learn from is the European Union’s (EU) biosimilars approval pathway, which requires an extensive testing process to ensure the safety of biosimilar drugs and incentivizes innovation by providing a decade of data exclusivity to companies which produce new drugs.
The Alliance for Safe Biologic Medicines (ASBM) advocates for a pathway that protects patient safety and incentivizes the innovation of new medicines in order to help improve health outcomes in the United States. The EU’s system meets these standards and we hope the FDA will study and learn from their system.