Speaking at the Goldman Sachs Biosimilars Conference this week, Diem Nguyen, Pfizer’s Regional President of Global Established Pharma, warned despite the US market beginning to open up, there is still a number of concerns surrounding regulations and access, in particular the issue of interchangeability between the reference biologic and its biosimilar.
“Interchangeability is one of those components where I think it needs to be driven by the science and the data,” she said. “The FDA has been falling short in terms of how they define interchangeability at this point, but certainly one of those aspects is that [there is not going to be] one decision for all of the biosimilars.”
According to the Biologics Price Competition and Innovation Act of 2010, an interchangeable biological product may be substituted for the reference product without the intervention of the healthcare provider.
However, industry is still waiting for guidance on the interchangeability data needed for submitting a biosimilar with the FDA and Nguyen said Pfizer is “still working through” a number of aspects with the Agency for interchangeability repercussions for its pipeline.
“If you do not have interchangeability, automatic substitution does not necessarily come into play, and that then drives this perspective of how you drive adoption, potential switching and how you distinguish between the brands.”
She added she would be “surprised if the agency had - based on our conversations - deemed interchangeabilities for the monoclonal [antibody biosimilars] that we are currently discussing today.”
Pfizer has five biosimilars in development – versions of Humira, Rituxan, Herceptin, Remicade and Avastin - and will add a number of others through its impending $17bn acquisition of Hospira.
No interchangeability in the near future
But while these products continue to be developed, Nguyen doubted whether interchangeability would become a reality for FDA-approved biosimilars in the next few years.
“I think that the FDA is going to be cautious and look at it on the data-by-data, asset-by-asset basis today whether an actual medicine becomes interchangeable or not,” she said.
“If there is data out there that suggests that there is a high degree of sensitivity that shows that they are as close to identical as possible, one could imagine that interchangeability could happen.
“I am not sure I could see that in the near future,” she added.