The hope of biosimilars is to provide therapeutically equivalent biologics at a reduced cost. The annual cost for patients with cancer, Crohns or rheumatoid arthritis can run in the tens of thousands of dollars and any cost savings on these therapies would benefit the health care systems. However, the hype assumes a “switch” from the brand to the biosimilar product. At this point, switching is not an option. Substitution of the biosimilar product for the reference biologic is the key driver in the cost reduction associated with biotechnology derived therapies. However, European practice typically does not allow biologic substitution. The BPCI allows the FDA to make the determination of interchangeability in a 351(k) application, assuming the interchangeable substitutable product is shown to be biosimilar to the reference product and meet the other standards described in section 351(k)(4) of the PHS Act. It is not clear the type of additional information (or costs) required by the FDA for interchangeability but may include extensive immunogenicity assessments between the reference and test products. Will the hope of interchageability be thwarted by the costs, time to market and return on investment?
Author(s): Robert Bell