Biosimilar Development Still Fraught with Challenges for Manufacturers

Executive at Pfizer discusses the various regulatory roadblocks and market challenges for biosimilars in a Q&A with Specialty Pharmacy Times.

With various estimates pegging the timeframe for biosimilars to finally gain approval in the United States at anywhere from 2 to 5 years, manufacturers are still diligently preparing for the opening of the domestic market.

A flood of patent expirations over the next several years has driven pharmaceutical companies to initiate educational campaigns to spread awareness on the unique aspects of biological manufacturing. Branded biologic oncology products alone currently represent more than $20 billion in global spending and are anticipated to be the top target for biosimilar development over the next 5 years, according to the IMS Institute for Healthcare Informatics.

Among manufacturers focused on preparing for the breakthrough of biosimilars is Pfizer, Inc, which is actively working on plans to aid biosimilars in gaining acceptance among physicians, pharmacists, and patients. Specialty Pharmacy Times spoke with Javier Coindreau, MD, vice president of global medical affairs for Pfizer Biosimilars Business Unit, about the various challenges and issues surrounding biosimilar development.

SPT: How is Pfizer preparing for the flood of upcoming biologic drug patent expirations?

Coindreau: We have a clear map of future biologics losing patents in the following years and some of the ways Pfizer is preparing is, first of all, timing. Time plays a critical role in the biosimilars market, unlike innovative products where you can stop and rethink things, redesign your clinical trials, and have a little more flexibility in terms of time. That’s not the case in the biosimilars world. One of the most important aspects is preparation. We need to have a clear long-term view of patent expiration. Secondly, the most important issue after timing is the quality of the biosimilar molecule. Having a molecule that is highly similar to the reference product, if we’re able to find it and develop it with the same level of quality, then everything else following that process in the development is going to be easier and faster. By having a high-quality molecule that is very similar to the reference product, it is more likely that we will find similarities at different levels more than a functional structural level.

SPT: What are main roadblocks preventing biosimilars from hitting the US market?

Coindreau: One of the most important roadblocks is clarity in the regulatory pathways. The pathways are evolving all the time, and this is especially true in the biosimilar world. The current regulation doesn’t provide the needed clarity for specific molecules. One of the most challenging parts is when we submit drug submission packages with the best analysis finding the best chance for being approved, sometimes we struggle in identifying what exactly are going to be the demands of the regulatory agencies because the current regulations have many grey areas that need to be clarified case by case.

SPT: How many years do you estimate it will be before biosimilars hit the domestic market?

Coindreau: My gut feeling is that it will be 3 or 4 years, for large molecules of course.

SPT: What kind of initial impact on the American market do you expect biosimilars to have once they are approved?

Coindreau: Of course we would like to get the most out of it, but we know the reference product, the innovator compounds, will also try to protect their market share as much as possible so I can’t really answer that question. Probably 30% to 50% of the market, depending on the drug and depending on the therapeutic area.

SPT: What disease conditions are poised for the biggest impact from expiring patents once biosimilars start to hit the market?

Coindreau: I think the most important ones will be those related to chronic inflammation in rheumatology, gastroenterology, and dermatology. Within those, probably psoriatic arthritis and rheumatoid arthritis will be the most important ones that could be affected. Another big group is the oncology and hematology area.

SPT: Is there a specific reason those conditions are poised for the biggest impact from biosimilars?

Coindreau: Because of the size of the opportunity and also because many of these conditions are treated with biologics, unlike other therapeutic areas, and also the fact that these are the first biologics that entered the market in the first place back in the mid-90’s. Those are the key drugs losing their patents.

SPT: Why is the availability of biosimilars an important issue for Pfizer?

Coindreau: One of the things biosimilars provide is competition, and with that the potential for increased access. One of the most important reasons biosimilars should be available is the need for these drugs are huge and in most cases, in these therapeutic areas, access is not easy. So by increasing competition, biosimilars increase access for patients requiring these drugs but who currently don’t have access.

SPT: With biosimilars already available in the European market, how can American manufacturers catch up in a meaningful way?

Coindreau: I wouldn’t say we’re too far behind, but there definitely is a need to catch up. One of the most challenging parts, in addition to the regulation I mentioned and is relevant to biosimilars hitting the market, is the ability to recruit patients for clinical trials. That’s difficult in the biosimilar world because patients and physicians think it doesn’t make sense. They think if I’m going to enter a trial, I’m going to do it for a new molecule not something that’s the same as the previous one. The challenge of recruitment is extremely important. This is true everywhere, not only in the US and Europe, but the rest of the world and it’s understandable for the reasons I mentioned. So one of the ways in which we can catch up with what is happening in Europe is by accelerating recruitment in our trials and to be innovative by making our trials more attractive and faster, maintaining the high quality and scientific rigor that is necessary for development. This will create trust, not only for Pfizer, but the other firms that are developing biosimilars, and with that it will be easier to recruit and get access.

SPT: What role will specialty pharmacists play once biosimilars hit the market and how important will they be in helping biosimilars gain traction?

Coindreau: Specialty pharmacists will be extremely important. I think all of the payer organizations will play a very important role in the success of biosimilars and providing more access to them. We know that for most of the organizations interested in having biosimilars, it is something for the benefit of themselves, society in general, and for other customers. The role of specialty pharmacies is going to be very important. One of the ways in which American companies can gain terrain in this biosimilar battlefield is by having innovative contact with pharmacies and payers in general, so their role will be critical.

SPT: What will specialty pharmacists need to do in terms of education once biosimlars are available?

Coindreau: Education is one of the most important words in the biosimilars challenge. We have a belief system that there are 2 categories of drugs, which are innovative drugs and generics. Sometimes when we speak with physicians, patients, and some payers, we try to accommodate them and put biosimilars into these preexisting categories. So the role of education is to show that this is a new category in which, no, you’re not an innovative drug but clearly you’re not a generic. This is a different pathway because the word biosimilar is a regulatory word, not a chemical word or a biologic word. The critical aspect of education is to show the value and quality of molecules and how they can be used in the extensive conditions for what the innovative drug is approved, and trust the process the FDA put in place. Education plays a critical role and many aspects of the education is different. At this point, I would say that payers in general understand very well the role of biosimilars and the general concept of biosimilarity. The opportunity is more on the patient and physician side where that concept doesn’t exist in the real world yet, so for that reason we and the payers need to prepare the field for that.

SPT: What needs to be done to educate physicians and the public on biosimilars?

Coindreau: I think the challenge for educating physicians and patients is very large and it has 2 components. The first one is to understand the biosimilar concept itself, how a biosimilar is developed, and what the scientific rigor is behind it. How everything relies on the structure of the molecule. The next step is to educate for the specific compounds that are going to be available on the market. Maybe the most important challenge in terms of education is to change the mindset that we don’t care about the molecular structure as long as it’s safe, it solves the problem, and it provides value. Nobody cares about the structure in medical practice. Here it’s completely different, because in the biosimilar world structure determines everything. That’s the reason we emphasize so much the quality of the structure and the similarity of the structure of the biosimilar candidate. This is something physicians and patients usually don’t think about. Until now it was not as relevant as it is currently or as it will be in the biosimilar world. So probably, the most important aspect in education will be to explain the importance of the structure of the candidate biosimilar and function of the candidate biosimilar. That is critical and that is a new concept.

SPT: How does Pfizer plan to increase education?

Coindreau: Scientific education around our compounds is critical. We do it all the time with every drug we have on the market and with new drugs we launch, and that’s not going to be different with biosimilars. Of course the content is going to be completely different because it is critical that all of our customers and stakeholders in health care practitioners, patients, etc, understand the biosimilar concept first before we start talking about our compounds. So I would say Pfizer will put forth an effort in educating on the science behind biosimilars.

We speak with physicians all the time. We speak with patient associations, with medical associations, advocacy groups, and we really see the need for education around biosimilars and biosimilarity. We need to find a way to communicate the importance of biosimilars and the high potential they have, especially the quality behind the molecules and how the entire concept of biosimilarity is based on the molecular structure of the candidate drug. It is a big challenge.