Road Ahead Still Difficult for Biosimilar Producers in the US Despite New FDA Guidance on Interchangeability
Following news that the FDA has finalized its guidance on interchangeable biosimilars, Rose Joachim, PhD, Senior Immunology Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the implications for Immunology saying the FDA’s new guidance is a huge step forward, however the new specifications will still make it a hard road ahead for biosimilar producers looking to make headway in the US.
The FDA has specified that it does not consider post-marketing or other single-switch studies sufficient to prove the interchangeability of the product, requiring manufacturers to conduct new multi-switch studies. To date, only two large-scale studies in the immunology disease space have been conducted in this manner, one for Sandoz’s Erelzi and another for Sandoz’s Hyrimoz, both for the treatment of plaque psoriasis.
Another factor that continues to complicate the utility of an interchangeability status on a biosimilar is the product’s pricing. Based on GlobalData’s analysis, in 2018, biosimilars commanded only 6% of the US infliximab market for rheumatoid arthritis, four times less than the 2017 European infliximab market over a similar launch period.
One of the main issues thought to be slowing the uptake of biosimilars in the US is biosimilar companies’ inability to provide competitive enough discounts to payers. Payers often have already negotiated volume-based discounts and other rebates with the company producing the reference product, making it difficult for biosimilars to compete. Even if a biosimilar is granted interchangeability status, if it ultimately cannot compete with the reference product on price, it will not be placed on a preferred tier.
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