Oncology, Inflammatory Diseases Top Targets for Biosimilar Development

Pfizer executive discusses the present and future of biosimilars.

On the heels of the first biosimilar to be approved in the United States earlier this year, questions remain as to the overall impact these drugs will have on spending.

The global market for biosimilars could hit $20 billion by the end of 2015 and may reach $55 billion by the end of the decade, according to recent analysis from GBI Research. The report noted that biologics currently comprise between 17—20% of the pharmaceutical arena, with a value of nearly $200 billion. The company finds that biologic drugs may replace 70% of chemical drugs within the next two decades.

Meanwhile, a report released in February 2015 by economist Alex Brill projected that even under favorable assumptions, only biosimilars for biologics with sales greater than $898 million would be worth the investment for manufacturers. As a result, biosimilars for biologics with a smaller sales market may never reach the market.

In light of these conflicting estimates as to the impact of biosimilar development, Specialty Pharmacy Times spoke with Javier Coindreau, MD, vice president of global medical affairs for Pfizer Biosimilars Business Unit, about the ongoing issues surrounding this fast moving area of specialty pharmaceuticals.

SPT: What is the status of Pfizer’s current biosimilar pipeline?

Coindreau: We have 5 molecules in development. Two are on the pure inflammation side, two are on the oncology side, and one that is used in both therapeutic areas, but is mainly used in oncology. All of these molecules are biosimilar candidates. Rituximab is an important molecule in chronic inflammatory diseases, particularly rheumatoid arthritis. Four out of the five are monoclonal antibodies currently in phase 3, so that’s where we are.

SPT: Now that the first biosimilar has been approved, are efforts increasing to get more out to market?

Coindreau: Probably yes, that is the expectation not only from biosimilar developers, but also from many payers across the country. We need to take this first example of a biosimilar and have to take it with some limitations in terms of how we learn. It is of course useful to know how the FDA behaves in terms of biosimilar approval and what is its vision. However, this was a small biologic. It is a recombinant drug whose structure is much simpler than the larger ones. So monoclonal antibodies may be a little different in terms of how they enter the market and the approval process itself. In general, the expectation is these molecules will enter the market very successfully and there are expectations in many areas. Especially most of the expectations from patients and physicians with the potential entry of biosimilars, the access to biosimilars, and efficiency in the budget of payers can be improved.

SPT: Do you think the high cost of research and development that goes into biosimilars will inhibit the market?

Coindreau: No I don’t think so. I think biosimilar development is a category that in itself will increase the research dedicated to biosimilars, and we’ll be able to develop biosimilars in a better and faster way as we learn. However, biosimilars will cover some unmet needs for patients related to access. But new biologics are still absolutely necessary for the treatment of other conditions in which the unmet need is medical, a biologic unmet need. So the research has to continue and the opportunity to grow in both directions is still there.

SPT: What other disease states are poised to see an impact from biosimilars?

Coindreau: I think it depends on the molecule. Going back to the pipeline, chronic inflammatory conditions will continue requiring the development of new biologics and biosimilars. We know that not everybody that needs monoclonal antibodies for the treatment of one of these chronic conditions, like rheumatoid arthritis, has access to it. There are some limitations in the access, not only in the United States, but worldwide. It may be even worse in other parts of the world, so the opportunity is still there in chronic inflammatory conditions. I’m not talking only about rheumatology, but also dermatology, Crohn’s disease, etc. There is an opportunity for the development of biosimilars for unmet medical needs. On the other hand, the oncology area requires better access and requires molecules that will continue being used, so this is a good example in which both biosimilars and new molecules can be used simultaneously in chronic inflammatory conditions and oncology. So one doesn’t replace the other, but there’s a synergistic opportunity to use both molecules together.

SPT: What still needs to happen from a regulatory standpoint for biosimilars to provide cost relief to consumers?

Coindreau: The evolution of the regulatory environment needs more clarity. Biosimilars, developers know very well, are evaluated case-by-case and at this point this is probably the right thing to do. There is no standard for what are the biosimilarity margins, for example. Each molecule is different depending on the molecular characterization. The margins for biosimilarity will be different from molecule to molecule when we move to the clinical development level. That natural lack of clarity is something we think will improve in time as we in the industry and the regulatory bodies learn more about the aspects that impact biosimilarity. But I think this is a natural phenomenon we have seen in the past and only experience will clarify many things.

SPT: Has awareness surrounding biosimilars across the US health care landscape improved since the initial approval in March?

Coindreau: Yes it has improved, particularly with some audiences it has improved dramatically. Those specialties that work in chronic inflammatory conditions and oncology physicians understand what the biosimilar promise and what the biosimilar science is. They know it much better now than in the past. You might ask what the metrics are for that, and of course there are no hard, objective metrics. But in the way that we have the conversation with different audiences, physicians, patients, advocacy groups, and regulatory bodies, it is clear that the dialogue is moving into a better understanding of biosimilars. That being said, it doesn’t mean the knowledge is there. We are all learning about biosimilars because it’s an emerging area that is evolving very rapidly, especially for the patients who are the most important part of this chain of groups that work together. Patients need to learn how biosimilars are developed, what are the advantages and disadvantages, what are the safety and efficacy issues of each one of the different biosimilars that will appear in the market.

SPT: What do you think the landscape for biosimilars will look like a year from now?

Coindreau: I would say that we have reached a point in which we know how to develop biosimilars and how to do it right. We are learning every step of the way from molecular characterization to clinical outcomes and clinical trials. Probably what we are going to be answering is how these molecules are going to be differentiated from one another. That is something I think a year or two from now is going to be critical. What is the emphasis of differentiation and the differentiation cannot come from the molecule itself because by definition a molecule cannot be different. They have to be highly similar. So differentiation will have to come from other aspects of what it means to develop drugs and commercialize them. Also, the competitive environment, which is already complicated, will probably become clearer with new drugs entering the market and new drugs potentially approved.