FDA Commissioner discusses challenges and opportunities for biosimilars

Biosimilars/General | Posted 06/10/2017 post-comment0 Post your comment

The US Food and Drug Administration (FDA) approved its first biosimilar for cancer drug Avastin (bevacizumab) in September 2017 [1]. In light of this momentous event, FDA Commissioner Dr Scott Gottlieb spoke to medical reporter Laurie MicGinely, at The Washington Post’s Chasing Cancer Summit, about the challenges faced by biosimilars and the future opportunities in the US.

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Dr Gottlieb said that FDA is currently reviewing 10 applications for biosimilars, and that 27 biosimilars developers have asked for guidance on their applications. Although he admits that the ‘pipeline in-house at FDA isn’t exceedingly robust’ he sees education as key to getting the ball rolling when it comes to uptake of biosimilars.

Dr Gottlieb sees the current situation with biosimilars as being similar to that for generics 30 years ago. He says that ‘there is reluctance on the part of providers to switch over, certainly to switch patients off of therapy that they’re on, onto a biosimilar, or even to embrace a biosimilar, especially if you’re thinking about curative therapy’. However, despite the slow start, he sees ‘a lot of development activity’ and expects ‘to see a real pickup in the rate of biosimilar development’.

FDA is spending money on public education campaigns to educate providers about the robustness of the process [2], but Dr Gottlieb thinks that ‘it’s going to be slow adoption’. However, this is where he sees ‘an opportunity where the payers might have a role to play by guaranteeing perhaps a market share to some of the biosimilars that are coming onto the market, and then driving the adoption themselves’. The risk, he says, is that ‘if the adoption rates continue to be slow, then the potential manufacturers of biosimilars won’t see this as a viable opportunity, and won’t make the investments in the first place’. He adds that ‘if they don’t think that they can capture 20 or 30% market share within the first five years of being on the market’ they might avoid biosimilars altogether.

He sums up by saying that biosimilars have the ‘potential to provide important competition in categories where the products, right now, could be exceedingly expensive’.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi
2.    GaBI Online - Generics and Biosimilars Initiative. FDA says trust and education critical for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 6]. Available from: www.gabionline.net/Reports/FDA-says-trust-and-education-critical-for-biosimilars

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Source: The Washington Post

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