Imron Aly, JD, partner at Schiff Hardin LLP, discusses the Biosimilar Action Plan's key features.
What are the key features of the Biosimilar Action Plan?
I would say there are 3 features of the plan that have caught my eye. One is education, 2 is interchangeability, and 3 is international data sharing.
For the first point for education that is key in the biosimilars world because the US has waited for regulatory agencies abroad to really take the lead and test and determine what would be acceptable to the market and to physicians. So in the US, part of the plan is to improve the education and outreach so everybody will have more knowledge about what’s happening around the world and what can happen here too.
The second part for interchangeability--what’s very important for any generic drugs to be motivated--is to be interchangeable for the brand and that way, so that there’s a prescription for the brand of course it can be interchangeable with and substituted by a generic. That is proven to be a high hurdle to biosimilars and part of the plan is meant to address that feature as well.
The third part is international outreach, and this is important, because the plan is trying to get information from other agencies, particularly the [European Medicines Agency, EMA] in Europe, to make sure that what they are doing is working and learn from it and actually try to implement it here in the United States.