An interchangeable biological product may be substituted for the reference product without the intervention of the healthcare provider, according to the Biologics Price Competition and Innovation Act of 2010.
In the US, four products have been deemed biosimilar to originator biopharmaceuticals, but none of these are considered interchangeable. The US Food and Drug Administration (FDA) has been criticised by industry for not developing clear guidelines on the subject, and last month pushed its timeline further back, pledging to publish draft guidance sometime before the end of 2017.
But why does interchangeability matter? That was the question posed to experts across various panels at last week’s CPhI Worldwide event in Barcelona, Spain.
80% unaffected
Specifically, Rakesh Dixit – VP and global head at AstraZeneca’s biologics division MedImmune – was asked during the preconnect congress why interchangeability is deemed “the holy grail” by biosimilar developers when 80% of all biological products are dispensed directly in the hospital setting and dictated by the physician.
Dixit agreed that only 20% of biologics would be affected by any interchangeability ruling. “However, sometimes perception is more important than the actual reality,” he said, as by not deeming a product interchangeable, the very nature of a biosimilar is undermined.
He also added that interchangeability would make a real difference in chronic conditions, for example, for patients taking AbbVie’s Humira (adalimumab) outside a hospital setting, and criticised “another year of delay” on the awaited FDA guidance.
During a lively media debate on the Tuesday, Biocon’s president and chief marketing office Ravi Limaye said while the long-awaited guidelines will help remove negative perceptions surrounding biosimilars, they will come naturally as more products enter the market.
“The belief is that as people gain experience and we see more and more biosimilars getting approved and as education levels go up, we will see the regulators supporting this, and some sort of guidelines will emerge in the next few years.”
European experience
He compared the situation with Europe, which has a decade of biosimilar experience and is less preoccupied with the idea of interchangeability.
Kate Kuhrt, head of GTM for life sciences at Thomson Reuters, did point out the remain differences in Europe to how different countries deal with interchangeability.
“My understanding is the interchangeability is governed at a country level, rather than being written into EU legislation per se,” she said. “In some cases there are rules not permitting switching, or where switching is only permitted under certain conditions.”
“This will raise questions as we see more biosimilar launches as to whether there will be interchangeability between biosimilar 1 and 2, or just between the originator and biosimilar 1.”
[In the EU, the definition of interchangeability differs: Substitution is done at a pharmacy level but requires a physician’s approval, while if a biosimilar is interchangeable it can be freely switched with its reference product (or another biosimilar) by a pharmacist.]