Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis, outlines how concerns over the safety and efficacy of biosimilars has shifted and what new concerns the industry is focusing on.
During an interview from the Festival of Biologics, Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis, outlines how concerns over the safety and efficacy of biosimilars has shifted and what new concerns the industry is focusing on.
How has the conversation surrounding biosimilars evolved since the US introduction of biosimilars in 2015?
Woollett: I think one thing that we saw had been somewhat put to rest in recent discussions is any questions around quality of the biosimilars or any unusual or unexpected adverse events, such that those that are experienced in their use are increasingly comfortable as further biosimilars come along.
But in that sense, it's slightly dependent on therapeutic area because say you've had experience with oncology biosimilars, you're comfortable with future oncology biosimilars. So, I think there was a discussion that the business model is more, perhaps, governed by therapeutic area than it is either a more generic model or a more brand model.
So, I think that was one important point, but it does come down to: the science is the bedrock of everything. That if you're consistent as a regulatory authority, it's important for both the confidence in the biosimilars but also the confidence in the regulators, that they're consistent and science-based.
There's an opportunity for much, much greater regulatory efficiency. And that came up, again, as a global issue, perhaps in part due to some of the experiences from COVID-19 but also a general agreement that the science is worldwide. And if we can show some regulatory efficiency, we can get more competitive products more quickly and more affordably. But also we may keep more competitors in this space. So, that was really important, too.
And then there was amongst some, not amongst everybody, the view that, of course, we need biosimilars to allow room in the health care dollar for the next tranche of innovator products, too. And that affordability across the board is as important as anything else to do with biosimilars insofar as everybody wants the originator biologics coming through. And of course, they're the future reference products for biosimilars. So, there was a little bit more optimism around the sort of virtuous cycle of ideas rather than being solely about specific products and some companies feeling a threat to their portfolios.