A biosimilar drug is a biological formulation developed in a way similar to an already-approved biologic, also known as the reference product. Biologics offer relatively cheaper treatment alternatives for patients suffering from chronic and often disabling indications like autoimmune disease, diabetes, and cancers. While one might think that biosimilars are akin to generic drugs, there are significant differences between the two. Generics are chemically identical to the branded drugs. However, a biosimilar is not a replica of another biological product. There is a level of natural variability in all biological products, and it is not possible to make an exact copy of a product that comes from living cells. All biologic, including reference products, indicate a few variations in batch-to-batch formulations.
* How are Biosimilars Regulated?
In the US, a regulatory pathway for approval of biosimilars was made possible by the BCPI act or Biologics Price Competition & Innovation Act. This act is a provision comprised in the Patient Protection and Affordable Care Act of 2010. The Food and Drug Administration (FDA) gauges the safety as well as the efficacy of all the new, original biologics. Evaluation of biologics is the same as for new conventional medications. The purpose of developing a biosimilar is to determine that the proposed biosimilar is highly comparable to the reference product, with similar safety and efficacy.