Ian Henshaw, senior vice president and global head of biosimilars at Biogen, shares his thoughts on whether clinical efficacy and switching studies to establish biosimilar safety are necessary, a hotly debated topic in the biosimilars industry.
Ian Henshaw, senior vice president and global head of biosimilars at Biogen, gives his thoughts on the necessity of clinical efficacy testing for biosimilar approvals, switching studies to establish interchangeability, and the promotion of biosimilars within company environmental and social impact reports.
Lately, there have been a number of efforts to try to remove clinical efficacy testing for biosimilars and to remove switching study requirements for establishing interchangeability. What is Biogen’s view on these efforts and do you think removing these requirements would create more confusion about biosimilar safety?
Henshaw: The intent of these discussions is to maybe open up the market. Some may see it as to lower the threshold. But we should recall that the body of evidence to get a regulatory approval is generally only the preclinical aspect. So, it's about the technical process, the manufacturing, etc. If we divide the clinical studies into 2, phase 1 and/or phase 3, you need to probably keep phase 1 for the right reasons, except in certain circumstances where you don't want to be putting an active drug into, say, an eyeball.
If you did, under the scenario that you did eliminate a phase 3 study, because the body of the totality of evidence found—for example, in Europe, is 1 million patient-years of data—you would then say, "Does that prove anything? Is it necessary in terms of confirming comparability between the innovator and the biosimilar?" In that circumstance, you wouldn't do switching studies, and therefore, you wouldn't have an interchangeability discussion.
But I think the discussion is, if the body of evidence is within the early preclinical stage, which is about comparability within certain tolerances and also includes a phase 1, you've probably covered most of the question marks around switching from one biologic to another biologic to another biologic, which, by the way, is what happens when you go from one innovative batch to another innovative batch to another innovative batch. They're all similar to the first reference batch, and I think that is where the body of evidence and real-world data starts to come to play and actually opens up the possibilities of this marketplace.
Earlier this year, The Center for Biosimilars® wrote a piece on how companies are using their biosimilar development portfolios as part of their environmental and sustainability reports and social impact reports. Why is it important for companies to establish how their biosimilar portfolios impact the world?
Henshaw: So, commitment to ESG [environmental, social, and corporate governance] is a long-term journey for everybody. That's number 1. I think number 2 is, we have been reporting on that at Biogen for some time. And number 3, when we look to the future and what we can do, most importantly, what our customers are now asking us to provide evidence on, they're asking us to provide evidence of our ESG credentials within some of the contract structure of tenders and contracts. And I think that's good. That's a step forward. Again, that will move forward as we start to think about some of our COP [United Nations Climate Change Conference] commitments across the across the world.