Diem Nguyen – Diem Nguyen, Regional President, Global Established Pharma
Biosimilars market still in nascency
“biosimilars market is still in its nascency today…It was less than a $1 billion in 2012 and it is growing to $20 billion by 2020.”
Evolution of regulatory pathways
“For the last two or three years, you have seen an evolution in the regulatory pathways, so before 2012, the only to get a biologic copy into the marketplace was to go through an innovative pathway.
With the recent guidelines established with the EMA and then with the draft guidelines with the FDA, what we have seen is more clarity into what expectations of the regulatory guidelines are.”
Between 2015-2020 will see more biologics going off patent
“in 2015 to 2020 is this perspective of innovative biologics going off patent. If you look at those two peaks of loss of patent expiry, the first is in the 2015 to 2017 time horizon, which is primarily dominated by the recombinant protein. Then you move to the 2018 to 2020 time horizon, where a lot of the monoclonals start losing their patent expiry.”
Biosimilars are not generics
“biosimilars are not generic. Reason for that is you are talking about generics as small molecules that are chemical entities, so what drives the development of generics are, one, demonstrating proof quality, two, PK data, and then being able to rely on existing clinical data from the label.’
Biosimilars are proteins that are developed on live cells or viral platform
“Biosimilars on contrast are proteins and these are proteins that are developed live cell lines or viral platform, so what you have here is the requirement is one proof of quality and similarity. You can’t have an identical biosimilar or they would be called bio identical. Those do not exist. You have the requirement of PK data, as well as clinical data to demonstrate comparability from a safety and efficacy perspective.”
Biosimilars demand trials
The contrast here in terms of the development of a biosimilar is we are looking at a Phase I as well as a robust Phase III clinical trial based most likely one or a few indications with some level of extrapolation. When I say robust, in general what we have seen from an FDA and an EMA expectations as you are looking at patient numbers ranging from the 600 to 800 patient trials.”
” a way to explain it just like in common layman term is, if you have two-by-two piece of wood, you can cut that two-by-two and it looks identical, and I think of that as a generic, but then you have a tree, which is your biosimilar, the proteins. If you look afar, all those trees looked the same, but their branches are actually quite different.”
Black swan biosimilar with adverse event
“I think one black swan that you might have is if there is one biosimilar that ends up having an adverse event and what does that do to the class effect of biosimilars and I think that is a component, we are having dialogues with regulatory agencies to be able to have a productive discussion on what we believe is necessary to develop a save biosimilar, I think will be not good to supply there, but for the industry in general.”
Biosimilars are mimicking assets that were developed 10-20 years ago
“When you look at the profitability of biosimilars, and if you take on many components, the first one is the price, but the second one is your cost of goods. If you think just about innovative assets, they were developed, 10 years, 20 years ago, with the [ph] platform that may not be as robust as the new state of technology that many are using today.
One of the clear components that we have is our eyes are, while we do think it is a hybrid branded model, we do understand it is multi-source. With that, we developed our biosimilars to have a very strong cost of good structure to allow us to effectively compete on price.’
Oncologists may be particularly receptive to biosimilars
“if you look at the oncology space, I think oncologists are generally comfortable with using a cocktail of medicines and the cocktail medicines includes older established products with innovative products to then be able to comprehensively treat patients.
If you think about biosimilars, that actually makes a lot of sense, so the ease of using a biosimilar in combination with other innovative medicines, I think, is something that oncologist maybe more receptive to.”