Intellectual Property Practice Group Co-Leader Imron Aly described the three key features of the U.S. Food and Drug Administration’s Biosimilar Action Plan: education, interchangeability, and international data sharing.
“For the first point for education, that is key in the biosimilars world because the U.S. 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,” Imron said. “So in the U.S., 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 drug [company] to be motivated — is to be interchangeable for the brand,” he added. “That has 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.”
Watch the clip here.