IBD Horizon’s ACG “The Dialogue®
37yo on adalimumab/Humira. Insurance requests switch to biosimilar Amjevita. How to approach?
- What is a biosimilar? Biosimilar is a biological product that is highly similar to reference or innovator product, but not identical and notwithstanding minor differences in clinically inactive components. Approval for a biosimilar is an abbreviated pathway. FDA allows for extrapolation of data for use of the biosimilar in all indications approved for reference or innovator product.
- Status of biosimilars in the United States? Over 650 biosimilars are under development. It takes 7-8 years to develop a biosimilar, costs $100-250 million. Several biosimilars are currently approved in Europe. Anticipate biosimilars in the US in 2018.
- Does the issue of extrapolation impact your decision for use of biosimilars? FDA allows for extrapolation of use of biosimilar with appropriate scientific justification. In other words, if biosimilar tested in RA, it can be extrapolated for use in CD once the biosimilar is approved. This is not done currently with an innovator biologic agent. We also have seen with current biologic agents, dose and route of administration varies among diseases.
- Can interchangeability of biosimilars be implemented in the US? This depends on your State laws on biosimilars.
Consensus: Biosimilars are coming. There are issues related to extrapolation and interchangeability. There may be a risk in non-medical switching, and more studies needed given potential risk for cross-reactivity and immunogenicity. There is confusion regarding names and branding. Will biosimilars really be cost-effective? If so, to whom – the Patient? Premiums? Payor?