Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains some of the challenges with proposals to allow the United States to import cheaper drugs from Canada or other highly regulated pharmaceutical markets.
Transcript:
Can you comment on what some of the regulatory challenges would be with importing drugs from Canada, or from other well-regulated nations?
I think the main issue—there’s 2 main issues. One, if you look at it from the FDA point of view, it really undercuts FDA’s authority because what you’re saying is that, even if a drug isn’t approved in the United States, it can come in to the United States and be marketed here, and FDA really has not say over it. I think that’s something the FDA doesn’t like, just from an institutional point of view.
On the safety side, though, I think there are some real concerns, because even though some of these products may come from well-regulated companies, the way the drug distribution system is now, you don’t really know where things are coming [from]. So, things may look like they’re coming from Canada, and they’re really coming from—I don’t want to disparage any countries—but you know, from a less well-regulated country.
Particularly with all the concerns that have been swirling around in recent years about drug counterfeits, once you open the spigots that way, it makes it almost impossible to prevent and stop these counterfeit products from coming in, or at least it makes FDA’s job much more difficult.
There actually is a law on the books right now which would allow imports from Canada, I believe, but the Secretary of HHS has to make a certification that it can be done safely and thus far, I think this goes back to, I want to say back to Bush but, thus far, no HHS Secretary has been willing to make that certification, and I think that’s because of drug safety issues.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
FDA Green Lights Second Tocilizumab Biosimilar
March 7th 2024The FDA has approved Fresenius Kabi's tocilizumab biosimilar (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous and subcutaneous administration options.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
BioRationality: EMA Announces Readiness to Waive Comparative Efficacy Studies of Biosimilars
March 4th 2024Sarfaraz K. Niazi, PhD, takes a look at the European Medicines Agency's (EMA) announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.
Samsung Bioepis Announces New Biosimilar Partnership, Regulatory Updates
February 27th 2024Samsung Bioepis provided multiple updates on its biosimilar projects, including a new partnership for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.