Understanding the Impact of Biosimilars on a Global Scale

Martina Weise, MD

While biosimilars for the treatment of patients with cancer have only entered the arena in the last few years, supportive care biosimilars have been used in oncology for about a decade.

Much like recent skepticism over the potential use of trastuzumab (Herceptin) and bevacizumab (Avastin) biosimilars in the EU and the United States, the introduction of biosimilars for filgrastim (Neupogen) and erythropoietin were also met with reluctance, according to Martina Weise, MD.

Now more than ever, though, physicians are beginning to understand the utility and benefits of biosimilars. This will lead to a more competitive market and price decreases for payers and improved access to treatment with biologicals for patients, Weise said.

OncLive: Can you discuss your session at the 2018 ESMO Congress, which focused on biosimilars?

Have there been challenges with the acceptance of supportive care biosimilars?

Why might people in the field be reluctant to accept biosimilars? Is that starting to change?

In an interview with OncLive during the 2018 ESMO Congress, Weise, head of Division Licensing 2 at the Federal Institutes for Drugs and Medical Devices, Germany, and member of the Committee for Medicinal Products for Human Use of the European Medicines Agency, discussed the journey of biosimilars as supportive care for patients with cancer, as well as the future of their use as treatment.Weise: I have been invited to talk about the success story of biosimilars in supportive care. It is mainly about filgrastim and epoetin, which have achieved a high market share. This may, at least in part, be due to the fact that these drugs are often provided by hospital pharmacies rather than being prescribed by individual physicians in private practice. In addition, over time, physicians could be reassured that biosimilar filgrastims and epoetins are just as efficacious and safe as their reference products. I am confident that the same will happen with biosimilar monoclonal antibodies for cancer treatment.There have been lots of challenges. The first biosimilar epoetin and filgrastim actually had been licensed in 2007 and 2008, respectively—so about 10 years ago. Many physicians have been very skeptical and several learned societies initially published critical position statements, especially questioning extrapolation from one indication to another. This was mainly associated with lack of understanding of the biosimilar concept and confusion about the “similar but not identical” paradigm. We have seen more recent physician statements, such as from ESMO, that there is a much higher acceptance level. That is also good news for patients, because their access to modern therapies with biologics will improve. In EU-member states where the use of biologics has been very low because of high prices, we are now seeing a dramatic increase in their use in patient care. In oncology, we are always looking to new drugs targeting new mechanisms of actions, with the hope that they provide more benefit to patients, especially longer survival. With biosimilars, you get more of an already known and approved drug. But, reducing costs for established therapies is the basis for being able to pay for newer and maybe more effective treatments in the future. The sustainability of our healthcare system will also depend on the use of biosimilars due to the competition and price reductions that they introduce to the market.

Oncologists now have a better understanding of the scientific principles of a biosimilar development, the foundation of which is the analytical-functional comparison of biosimilar and its reference drug rather than clinical trials that clinicians are used to rely on. If the biosimilar shows high similarity to the reference product, then it can rely on the efficacy and safety experience that has been gained with the reference product. Understanding all that much better, the acceptance will be much higher.

Is there anything else that is important to mention about the current state of biosimilars?

There is still a challenge for monoclonal antibodies with regard to extrapolation between different therapeutic areas, such as oncology and rheumatology. European Public Assessment reports on licensed medicinal products are available on the homepage of the European Medicine Agency's website and are now more widely read. There, regulators are trying to be very clear about the basis for extrapolation—trying to explain it. I hope we are doing now better than we did 10 years ago. The important message is that it is going in the right direction. There will always be believers and non-believers, but, overall, physicians and patients are increasingly comfortable with using biosimilars. We can say that we have more than 10 years of experience with biosimilars on the market, and not one of them was withdrawn due to efficacy or safety concerns.

We need to build more trust in the regulatory system. The hurdles for approval of biosimilars are high, and several of them have been rejected or withdrawn for various reasons. For example, because the quality was not up to standard, they missed showing similar pharmacokinetic profiles, or there were too many other uncertainties. Not everyone makes it to the market; we are pretty stringent.