Biosimilars Forum Member Spotlight: 5 Questions For Samsung Bioepis

The Biosimilars Forum is comprised of companies with the most significant U.S. biosimilars development portfolios. Today, we’re highlighting Samsung Bioepis. Albert Kim, Vice President and Commercial Strategy Team Leader at Samsung Bioepis, disucsses the biosimilars landscape and Samsung Bioepis’ role in it.

Biosimilars Forum: The FDA has recently approved SB11 (brand name Byooviz®, ranibizumab-nuna). Developed by Samsung Bioepis, SB11 is the first ophthalmology biosimilar to receive FDA approval. What is the significance of this milestone? With its additional approvals in the European Union and the United Kingdom, what role can biosimilars play in the ophthalmology space in the U.S. and throughout the world?

Kim: The approval for the first ophthalmic biosimilar in the United States, and also the European Union and the United Kingdom is monumental as we are one step closer to realizing the value of biosimilars in the field of ophthalmology, where patients can benefit from wider access to biologic agents.

Ranibizumab is a biologic that has been considered a gold standard of care for wet age-related macular degeneration. Availability of this effective treatment had significantly reduced the disease burden for patients, helping to reduce the number of visual impairment caused by AMD.

However, one of the challenges patients have been facing is the high cost of treatment, and under-treatment has been pointed out as one of the issues when it comes to real-world practice with ophthalmology medicines. Having these additional treatment options will allow patients to have a greater chance of receiving treatment at the right time and ultimately lead to greater prevention of blindness as well as contribute to reducing the financial burden on healthcare systems.

As this is the first ophthalmic biosimilar approved, we do realize that there is a lot of work to be done, especially with physician education. Biosimilars were new to rheumatologists and oncologists five years ago, and we have seen physicians become more well-informed and confident in using biosimilars as real-world evidence and use of biosimilars grew over the years. Ophthalmologists are also new to biosimilars, and we will work closely with the industry and medical society to bring greater understanding of biosimilars so that physicians can make informed decisions when prescribing biologic agents.

Biosimilars Forum: What do you think are the biggest barriers to biosimilar access in the U.S., and what can the industry do to overcome those barriers so more patients can access biosimilars?

Kim: While prescription of a biosimilar is largely determined by the formulary status in the United States, complexity of the market system, along with various stakeholders involved in the value chain and diversity of the system and practice across different states make it more complicated for biosimilars.

While we still see some room for greater uptake and wider use of biosimilars in the United States, we believe the market is going in the right direction. For instance, we are seeing faster uptake with more recently launched biosimilars, with trastuzumab, bevacizumab, and rituximab, which have captured about 60% of the market share on average. While the market uptake differs for different therapeutic areas, we see this as a positive sign that stakeholders’ acceptance is improving.

While there are positive signs, there are remaining areas for improvement. For instance, many biosimilar manufacturers still face patent challenges by originators and have to wait many years to enter the market.

And when it comes to systemization of incentives to drive the use of biosimilars, do we have enough incentives for all the key stakeholders to drive the adoption? We talk about the cost savings benefits of biosimilars, but do physicians and patients benefit from the savings? Physicians are now better informed about biosimilars compared to the past, but is there any differences in the level of acceptance across different clinical settings or different groups of physicians? Also, when it comes to decision making on biosimilar conversion, hospitals and clinics have to consider many practical issues including inventory management and logistics, which may lead to slower adoption for some practices.

There is no one solution to these different challenges, and it would require collaborative efforts by the industry, medical society and regulatory bodies to find the key areas to focus, in order to address the key challenges and find possible solutions together.

Biosimilars Forum: Biosimilars can compete on price, but can they compete on quality?

Kim: All FDA-approved biosimilars are FDA-approved products, rigorously vetted on their safety and efficacy compared to the reference product, and there’s not a second class approved product when it comes to biosimilars.

But biosimilars can differ in terms of the manufacturer’s “ability to control quality,” which comes from the company’s capability and experience in biosimilar development and manufacturing. Biologics are very sensitive to external conditions, and maintaining consistent product quality throughout the development, manufacturing, and supply process and between different batches of the same product requires stringent quality control for manufacturers. This would require companies to develop high-quality products in the first place, and to put a systematic quality control system in place to monitor and maintain consistent quality all the time. In addition, biosimilar companies implement rigorous pharmacovigilance efforts, which have led to accumulation of real-world data on the safe use of biosimilars for many years.

“High quality” is also associated with maintaining consistent supply of products according to market demands, and adhering to good manufacturing practice. Companies can also find ways to “improve” the existing product to make it more patient-friendly, for instance, by improving the device to make the injection easier for patients with specific physical conditions.

There are various ways to “compete” on quality, and the key to success would be finding the unmet needs of the market where the company can bring unique value, and to bring viable solutions to meet the unmet needs.

Biosimilars Forum: What potential do you see in the U.S. market in the coming years?

Kim: In the United States, biosimilar adoption has been accelerating, with more recently launched biosimilars capturing a significant market share at a faster rate than previously launched biosimilars. We see this as an encouraging sign that the market’s acceptance of biosimilars is improving.

As patents for branded biologics continue to expire in the coming years, there will be more biosimilars introduced across different therapeutic areas, and more biosimilars will find their place in payor formularies, healthcare systems and institutions that are seeking to achieve cost savings.

The most anticipated development in the coming years would be the expected launch of Humira biosimilars, which would be happening in less than 2 years. 2023 will be an inflection point and it would be interesting to see how the market would be formed, as adalimumab is a pharmacy benefit medicine, which is different from previously launched biosimilars such as infliximab or oncology medicines.

Overall, we believe the US market is evolving in the right direction, and greater competition will foster a healthier market environment, which can lead to cost savings as well as more headroom for innovation.

Biosimilars Forum: What other exciting developments does Samsung Bioepis have on the horizon in the biosimilar space?

Kim: As a company dedicated to realizing the potential of biosimilars by providing high-quality medicines, we will continue our efforts to bring wider access to these important treatment options for patients who don’t have access to biologic medicines.

As part of our efforts, we are continuing to expand our biosimilar portfolio across different therapeutic areas where there is demand for wider access to treatments. We have SB12 (eculizumab), SB15 (aflibercept), SB16 (denosumab), SB17 (ustekinumab) in Phase 3 clinical trials and several other biosimilar candidates are in early stage development. We will continue our clinical development and regulatory affairs efforts to bring these affordable treatment options, so that more patients can receive the treatment they need.