Mark Pegram, MD
It is only a matter of time before more oncologic biosimilars become available as patent expirations are upcoming for several reference products in the field, said Mark D. Pegram, MD.
The European Union can be used as a blueprint of how the biosimilar market could quickly rise to prominence in the United States. Europe is a few years ahead of the United States in terms of patent expirations, Pegram said, and biosimilars have since taken off.
Pegram, co-director and professor in the Molecular Therapeutics Program and director of the Breast Oncology Program at Stanford University Comprehensive Cancer Center, said that although it is too early to attach a concrete discount rate with biosimilars, a potential 25% or 30% cost reduction represents billions of dollars in overall savings.
For those who are skeptical regarding the equivalence of biosimilars, Pegram mentioned the complexity of manufacturing biologic agents. Every molecule in a specific batch can be slightly different from another; it is almost guaranteed that these drugs vary significantly from batch to batch, he said. However, the FDA has also set rigid guidelines for biosimilar products.
In an interview with OncLive
, Pegram highlighted the gradually evolving landscape of biosimilars and provided insight on how they can shape the US market.
OncLive: What future impact will biosimilars have in the oncology space?
: Biosimilar drug development in oncology is a very fast-paced and exciting field. An opportunity presents itself because of patent expirations that are upcoming in the next couple of years for several biologics currently on the market. As those patents expire, that creates a framework for more biosimilars to be used commercially. Historically, non-oncology biosimilar products tend to be cheaper; consequentially, this opens the doors to new markets on a global scale.
This is particularly the case in some other countries where they literally do not have access to some of the generic drugs because of how costly they are. In each case of non-oncologic and supportive oncology care products, biosimilar products expanded the market significantly when they became available. This is good for patients. Now, we have opportunities for patients that were not there before because of cost.
Moreover, the rise of biosimilars has cost-saving factors, even for insured populations in the United States. The money that used to be spent supporting profit margins for pharmaceutical companies can now be spent on research and other [development efforts].
How would you address those who are still skeptical about biosimilars?
In terms of cost, it is true that manufacturing a biologic drug product is very complex and very expensive. Biosimilars will not be [discounted 50%]; let's just assume that. It will not be that significant of a cost difference. However, it could be a one-third discount for patients—this is more in line with projections we have seen in recently published literature. These won't be “fire sales” by any stretch of the imagination, but because the current products are so expensive, 25% or 30% off that price is still going to equate to billions of dollars in savings.
This has already played itself out in Europe because their patents expired a few years before they will in the United States. Biosimilars have taken off at a brisk place there. Based off of Europe's experiences with these drugs, we have a pretty longstanding track record of what to expect in the United States in the near future. There is just no doubt that biosimilars will gain traction.
In terms of similarity of these large, complex biologic molecules that are manufactured from living cells, it is almost guaranteed that every molecule in a specific batch will be slightly different from each other. Naturally, there are going to be post-translational modifications, some of them even clinically important. However, as we grow into biosimilars, we will be able to measure those attributes so precisely that we can come up with a panel of important attributes and compare it head-to-head with the reference products.