ABP 980 is a biosimilar that has been being developed to trastuzumab, which is also known as Herceptin. So that’s a product that’s made in living cells so Amgen has then also made its cell system to be highly similar, produce a protein that’s highly similar to Herceptin. There are probably two keys there, one is we use the same scientists and the same laboratories and the same manufacturing network to develop and produce our ABP 980 as we do all of our innovative medicines. Then the second is where we are in the development, as you asked, is we’ve completed the phase III programme and clinical programme and actually have submitted to the agencies for approval. This is a potential turning point for biosimilars in that this will be potentially the first therapeutic antibody biosimilar.
How, clinically speaking, closely does it match to trastuzumab?
It very closely matches that of trastuzumab and we look at it in three ways in order to be able to assess that. We start with the analytics, the foundation looking at the structure and function of the two proteins compared to each other. We have a highly similar product when you look at it through approximately a hundred different assay attribute combinations, how we look at the protein in so many different ways. We are highly similar there. The pharmacokinetics is the second piece and we have done a bioequivalence study in essence and showed equivalent pharmacokinetics. Then the last study which we have rolled out the data here at ESMO is a clinical study showing safety, efficacy and immunogenicity is highly similar as well.
Like you said, that goes out to agencies and in terms of approval barriers do you see anything holding it back?
I don’t see anything in particular and it’s obviously going to be an agency decision. But the overall evidence that we’ve put together in the package for the agency to review, that’s the structure and functional comparison, the pharmacokinetic comparison and the clinical trial. Maybe it’s important to note the design of that trial because that’s going to be something important for the agency to consider is that it was in a very sensitive population for efficacy, in the neoadjuvant setting, has also a very sensitive population for safety and immunogenicity in the adjuvant setting. So they have a lot of data to evaluate its similarity.
Going forwards into clinics for people in practice is there anything that you think would recommend the biosimilar over the original trastuzumab, even if it’s just a matter of cost per dose?
The important idea of biosimilars is that it provides a new therapeutic choice or an option for the physicians and patients as long as it’s high quality, that’s a key point for them to really make this choice, which Amgen does have that same high quality standard as our innovator medicines. So by providing this additional choice we hope it does help the healthcare system in its cost structure, in having an enduring healthcare system, as well as the ability for the healthcare system to support innovation and therefore gives their physicians a lot of choices in treating patients with the current therapies as well as future therapies.
Finally, maybe just a few broader thoughts on the future of biosimilar therapies in oncology.
I do believe that biosimilars are a new therapeutic class in essence, it’s not exactly [?? 3:29] and it’s certainly not that of a generics model. It’s a very important new class because these are critical medicines, the biologics, but they’re critical for treating and, in this case, curing patients of cancer. It does provide that option to have increased access to these important therapies and, like I said, reduce costs for the healthcare system. So there are multiple benefits to these products, again as long as there is no compromise. You don’t want to trade off an option of questionable therapy for cost so it has to be still with proper robust scientific standards and high quality manufacturing so that there is still the same confidence in the efficacy and safety of the product. That’s what Amgen provides with our biosimilar pipeline.
That covers past, present and future, was there anything else that we didn’t get to mention?
No, I just would highlight the excitement here that we’re seeing at ESMO for biosimilars and particularly ABP 980 which is the trastuzumab. This is the potential first therapeutic antibody that’s a biosimilar so that’s, in essence, a turning point for biosimilars with regards to oncology treatments.
