Part 1: Samsung Bioepis Executive Shares Developer Perspective on Biosimilar Switching Studies, Clinical Efficacy Testing

This written Q&A, featuring Kyung-Ah Kim, executive vice president of Samsung Bioepis, is part of a 3-part interview series expanding on the discussion from our LinkedIn Live event “In Sight: The Future of Biosimilars in Ophthalmology Care.”

Part 2 will be a podcast episode cataloguing the FDA’s efforts to increase confidence in ophthalmology biosimilars. Part 3 will be a video interview about the initial market response to ophthalmology biosimilars and how industry leaders can work together to increase uptake.

What factors are companies looking at when deciding which markets are worthy of investing in to develop a biosimilar?

Kim: We are applying more and more rigorous standards and setting a high bar when it comes to choosing the next therapeutic candidates.

Beyond our fundamentals, we assess the market size, which reflects the patients’ needs, the latest landscape of other biosimilar development status, and whether we will be the first market entrant.

How are biosimilars being used to address health equity concerns both in the United States and around the world?

Kim: It is important that patients receive the treatment they need and in a timely manner, and patients should not be limited from accessing treatments just because of cost of care or cost of medicines. Biosimilars provide competition to mitigate high prices and provide more treatment options as more patients are treated.

Global spending on health care is rising partly due to the rising cost of medicines, and we believe the adoption of biosimilars can play a significant role in reducing drug costs across various therapeutic areas, including oncology, immunology, and ophthalmology.

What are biosimilar companies doing to improve patient and provider perceptions about the safety of switching from a reference product to a biosimilar?

Kim: We have been presenting scientific data at medical congresses and our medical education activities will continue in the years ahead. We are publishing peer-reviewed papers that help physicians and other health care providers understand the science that is core to biosimilarity, such as structural, physiochemical, and biological characteristics of biosimilars as well as sub-analysis of comparable safety and efficacy-based clinical studies.

What are Samsung Bioepis’ predictions for how the adalimumab market will play out over the next year as up to 10 biosimilars are expected to launch by July 2023?

Kim: With our infliximab, trastuzumab, and ranibizumab biosimilars launched in the United States, we have seen how the market reacts differently over the years for different molecules, partially due to varying level of understanding and experience with biosimilars among stakeholders, differences in how medicines are distributed, supplied and reimbursed for each molecule.

I am a scientist so I can only give a general prediction, but I think the general expectation from the market is that adalimumab biosimilar adoption would be relatively slower during the first year of launch and it would gradually take off during and after 2024.

As a company dedicated to biosimilars for over 10 years, we have confidence in our product with our strong supply capabilities and patient-centric attributes, along with extensive market experience accumulated over 4 years in markets outside the United States with approximately 87 million days of patient experience.

What is your view on the relevance of interchangeability, especially in treatment spaces where medications are treated under the medical benefit, such as ophthalmology?

Kim: An FDA interchangeability designation enables a pharmacist to make a dispensing decision to substitute a biosimilar for its reference product—it is not about prescribing at all. As such, it is only relevant to pharmacy-benefit medicines that the patient self-administers. It is a legal distinction, unique to the United States, that allows pharmacists (subject to their state law) to dispense the biosimilar without consulting the original prescriber, although that provider will be notified. Thus, the interchangeability determination made by the FDA may not be relevant to medications administrated by physicians since those physicians can prescribe any medicine for any condition just as is the case with all other drugs and biologics.

Another important key point that we should be clear about when discussing interchangeability is that the biosimilar itself is the same whether or not it has an interchangeability designation. The interchangeable biologics are the very same biosimilars upon which additional studies may have been done and the designation does not denote any change in quality, efficacy, or safety.

How do you feel about the possibility of removing clinical efficacy testing and/or switching studies requirements for biosimilars? Would removing these requirements impact patient and provider confidence in biosimilar safety?

Kim: Omitting clinical efficacy testing and/or switching studies for biosimilar approval is being discussed globally given that the experience with biosimilars has shown that the analytical match is sufficient along with a pharmacokinetic (PK) study. A more tailored approach for demonstrating biosimilarity, that does not routinely assume the need for comparative clinical efficacy and safety studies, would enable streamlined biosimilar development with this leading to more biosimilar market entrants and increased patient access. We believe that it is appropriate, ethically and scientifically, to only do studies that give sponsors and regulators actionable information.

Current experiences across highly regulated markets have shown that analytical studies and human PK studies are sufficient in adequately demonstrating the similarity between a biosimilar product and its reference product. Not a single non-approval has been caused by a finding of clinical inequivalence between a biosimilar candidate and its reference when the 2 products had been found earlier to be highly similar in analytical and human PK studies. It is accepted across regulatory authorities that the comparative clinical efficacy studies are less sensitive to compositional differences than the analytical and PK studies.

As such, patients and providers can have every confidence in biosimilars without the expense and delays such studies incur—indeed the biosimilars made available to them will be exactly the same without those additional clinical studies and just as safe and effective as their reference products.