Winning Buy-In On a Biosimilar


(ACR14) (VIDEO) In tests so far, the infliximab biosimilar BOW015, just approved in India, seems to look about the same to the human immune system as the original. Here, a VP of the company behind BOW015 talks about the realities of seeking approval in the US.

In a Phase 3 trial, a biosimilar has shown efficacy and toxicity results similar to the "innovator" (original) infliximab , in combination with methotrexate for rheumatoid arthritis.

In this brief video interview, Michael Wyand, Senior Vice President of Clinical, Regulatory and Manufacturing at Epirus Biopharma, whose BOW015 biosimilar is soon to be released in India, discusses the procedures and prospects for gaining approval in Europe and the United States.

"A lot is going on behind the scenes," he says.

The questions:

•   Your study was a two-arm crossover design against the index drug. Why didn't you just do a head-to-head study?

•   What did you find with regard to adverse events?

•   Did you look at the nature of the events as well as the frequency? Was it similar on both counts?

•   In terms of what we know about the immunology, you followed out to one year. Do you think that's sufficient to know whether there will be immunogenicity problems down the road?

•   This drug has just been approved in India and you're about to launch there. Is that correct?

•   Of course you have a much different regulatory situation here. What can you tell us about the prospects for approval in this country, and the barriers and obstacles you may face?

•   Is it your sense, being in the industry, that people manufacturing or trying to market biosimilars are still in a sort of wait-and-see mode about the US regulatory situation?

•   Everybody is concerned about the cost issue ... How do you answer that?

Key quotes:

We had two different assays for the study we used. One was directed against Remicade. One was directed against BOW015. We tested all the patients with both assays, and the patients responded similarly in both assays, which tells me that the body sees both molecules very similarly.

The big issue on the regulatory front ... that's difficult for the biosimilar companies to deal with is the fact that there have been some very strict requirements on using the reference molecule, the innovator molecule, from the regulatory region that you're doing your study in, which of course makes it very difficult if you're doing the study in Europe ... The US almost forces you to repeat the trial.

I think costs will come down. They will come down significantly as competition puts pressure on pricing.


Kay J, Wyand M, Chandrashekara S et al.BOW015, a Biosimilar Infliximab, in Patients with Active Rheumatoid Arthritis on Stable Methotrexate Doses: 54-Week Results of a Randomized, Double-Blind, Active Comparator Study. Abstract #L20.  2014; 66:S1306. Abstract Supplement, 2014 ACR/ARHP Annual Meeting

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