Automatic Biosimilar Substitution and Patient Education Advocated by Elena Wolff-Holz, MD

Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, supports automatic substitution of biosimilars at the pharmacy, citing that Europe often grants this immediately with marketing authorization. She highlights interchangeability in the US specifically refers to automatic substitution, and BMAb-1200 (Yesintek; ustekinumab-kfce), has achieved this status.

Wolff-Holz emphasizes the importance of patient education at the pharmacy, especially if a biosimilar involves a different administration device compared with the originator drug. She explains how pharmacists would be responsible for explaining these differences and stakeholders would highlight any distinctions and provide necessary educational materials.

This transcript was lightly edited for clarity; captions were auto-generated.

Transcript

How do you feel about automatic substitution of biosimilars at the pharmacy level, and what safeguards do you believe are necessary?

I think automatic substitution at the pharmacy level is an option, it’s possible, it should be possible. I think this whole discussion on interchangeability that are granted in Europe immediately with the granting of the marketing authorization, and then at a national level, the automatic substitution can also be decided. Several countries, I think most recently, France, has accepted that, but other countries, also in Europe and in the United States, have a slightly different definition of interchangeability, in the United States compared with Europe. In the US, interchangeability really speaks to automatic substitution and if you can solidly justify that, and it is justified for Yesintek, so we've been granted the interchangeability status, then I think it's absolutely possible to do it. It's a clear, clear option.

I think what may have to happen is patient education also at the pharmacy level. If there were different devices, different ways that the drug would be applied, for example, also by the patient himself or herself, then it is important that the pharmacist takes on also the responsibility of educating the patient that there are maybe slightly different features in the apparatus, but it's not the drug, it's how you apply the drug. I think this is absolutely possible. I think we as a company, if there were differences to the originator, would then need to highlight this and bring out the materials, or make sure the pharmacist is aware of that. This could be an aspect, but so far, I don't think it is a problem.

What are the biggest misconceptions the general public has about biosimilars, and how can your research help to correct those misconceptions?

I think there could be an unfounded fear that something that is cheaper is less good, and that's why I don't like the word cheap, because it's about affordability. These are more affordable; these are not cheaper products, but more affordable products. They are highest quality, they have to go through a very rigid regulatory process, and at the end of the day, they have been applied to human subjects.

Our research has proven that. We've done all the analytics. We've done more than 100 orthogonal assays to look that really all the characteristics are the same. We've done a PK [pharmacokinetic] trial, where the dose curves are absolutely superimposable. Plus, we also did the phase 3 efficacy trials. Not only have we confirmed the analytical data with the PK trial, but also, all of those data with a phase 3 trial. There's absolutely no need to be fearful.

The other aspect is, I think, in the clever clinical trial design that we have, we've integrated the switch for those patients. Half the patients that were originally on Stelara, at week 16, they were rerandomized in a 1:1 split. Either they stayed on the Stelara or they then took the BMAb-1200 and we carefully monitored whether there would be a change in the effect or in safety or immunogenicity. We saw that there was no difference. Preswitch and post switch was not impacted, and all these are very solid data that really should ascertain and give the confidence to the patient, to the physician, and ultimately the payer, that these are high quality drugs.