The Future of Biosimilars: Opportunities and Challenges in the Global Market

As financial savings and patient benefits, such as health insurance, are emerging as major issues both domestically and globally, biosimilars that have the same effect as the original and are cheaper are expanding their presence.

In addition, a flood of biosimilars is predicted due to the expiration of patents for blockbuster treatments, and infinite competition in the future global market is predicted. As a result, Europe and the US are already taking preliminary measures to break down the boundaries, such as allowing interchange between original treatments and biosimilars.

As a result, Samsung Bioepis and others are rushing to launch biosimilars in Korea, but positive and negative opinions are still mixed in the clinical field due to the reimbursement system.

The experts who gathered at the special discussion meeting arranged by the Medical Times made it clear that there was no disagreement about the positive function of biosimilars. However, it is pointed out that there are still many hurdles to overcome in order for biosimilars to demonstrate a long-term presence in the global market beyond Korea.

The discussion was attended by Hong Seung-jae, insurance director of the Korean Society of Rheumatology (Kyunghee University Hospital), Lee Seung-gyu, vice president of the Korea Bio Association, and Kim Tae-hyun, head of Samsung Bioepis’ Korea business division. Three experts answered questions from the Medical Times. The following is a question and answer.

As the biosimilar industry matures, so does the market. How do you evaluate biosimilars at this point?

Kim Tae-hyeon (Hereinafter referred to as Kim) = Treatments released in the early 2000s are undergoing a paradigm shift starting in 2020. From now on, when important blockbuster products expire, one of the main topics is how to form a market worth hundreds of trillion won next.

In the early days, there were doubts about the safety of biosimilars and issues related to the protection of the domestic industry of the country that makes original treatments. Looking at the domestic market, demand is showing a rise, so we evaluate it positively.

Vice Chairman Lee Seung-gyu (hereafter referred to as Lee) = In the field of pharmaceuticals, it is difficult for latecomers to catch up and advance into the global market. In this respect, domestic companies’ global competitiveness through biosimilars can have great energy when viewed as a whole in the bioindustry.

The biosimilar market is expected to form a market of about 160 trillion won by 2025. So far, the industry has successfully grown well, but in a situation where there is a high possibility of becoming a red ocean in the future, strategy will become important.

Hong Soong-jae Insurance Director (hereafter referred to as Hong) = The meaning of the word biosimilar goes beyond the meaning of the same (Same) and even the concept of bio bette is emerging. Considering advances in immunology, genetic engineering, and engineering, biosimilars were developed late, but rather, I think they have strengths as innovative technologies are applied.

Since the introduction of biosimilars, what impact has it had on the industry and clinical field?

Hong = From the perspective of the global market, the Korean market and domestic patients are minor. In this respect, the biggest impact of the emergence of biosimilars developed by domestic companies is the increase in patient benefits. Beyond simply cost, patients’ discomfort is reflected in the development process, and there are many positive aspects in patient support.

In addition, although I did not think of it when I first introduced biosimilars, I think that there are many opportunities for patients and doctors, such as developing ideas that came up in the clinical field through smooth communication, and that there is a positive effect in terms of the quality of care. Biosimilars need to be more active in the future.

this = The process for latecomers to new drugs is clear, but it takes a very long time, although there are ideal paths such as preclinical, clinical, technology transfer, and FDA approval in search of good substances. Currently, at a time when the domestic biopharmaceutical industry continues to invest in global clinical trials and builds up energy while failing, biosimilars greatly reduce this period.

Kim = Looking at the biopharmaceutical ecosystem, the next 10 years is the turning point and the most important period for the expansion of the ecosystem. This is because the biosimilar field started with the view that it was the first blue ocean, but now competition is intensifying and it cannot go the same way as before.

It is believed that how to reinvest the stable cash flow prepared through biosimilars will be a hot topic in the future. I think each company’s new drug development will naturally continue.

Despite the positive evaluation, there are opinions that the limitations of biosimilars are clear in Korea. What do you think?

Hong = I think it is a matter of experience if the perspectives on biosimilars in the domestic market overlap. New treatments are unfamiliar, and efficacy, safety, and patient preference are taken into consideration, and the same is true for original treatments.

The patient’s question is simple. It is the same approach as whether there is a difference between imported and domestic products. There were such concerns at Celltrion, but I think Samsung made a great contribution in that it jumped into development and broke that idea. There are far more countries around the world that cannot make such a treatment, and we are talking mainly in the United States and Europe, but there are many opportunities for expansion, such as Southeast Asia and Latin America, which are growing.

Kim = Since biopharmaceuticals are expensive products, the approach steps vary greatly from country to country. As companies are making efforts to export more with the same momentum as K-Bio in the future, I think that future expandability is great.

Looking at the domestic situation, in Europe and the United States, government systems and academic guidelines have come out, and clinical trials and patient education programs have been strategically entered into a wide range, but Korea is now at a point where (prescription) changes a lot. It is also growing rapidly in Korea, and it has been analyzed that over the past 7 years (2016-2022), it has saved about 1.25 trillion won or more in finances.

Hong = It is good to experience the treatment directly in the clinical process, but if not, you have no choice but to experience research data. Since a certain period of time has passed since the introduction of biosimilars, a lot of changes in perception have occurred and doubts have decreased, creating an ecosystem.

The government is expecting the growth of biosimilars as one of the pillars of K-Bio. What kind of support do you think is needed for biosimilars to play a role as a bridge for the development of the pharmaceutical industry in the future?

this = When I looked at the cases of companies like Samsung Bioepis and Celltrion, I think it showed what the government can help and what role the private sector should play to grow the industry. In order to survive the competition in the biosimilar market, if the government creates a concrete platform within a short period of time and private companies enter the market aggressively, the possibility of creating a global brand can be increased.

Kim = In the case of generic development, it cost less than 10 billion won, but biosimilars are at least 100 billion won. As much as that, there is a consensus in that companies have a burden on R&D and need tax support or institutional support in order to contribute to national competitiveness in the future.

Even at the commercialization stage, countries such as the United States and Europe are encouraging various incentives at academic societies or countries. In a situation where health insurance budget reduction is a hot topic and the proportion of prescriptions for similar drugs increases, it is expected that if drug price incentives or equivalent drugs are announced at the government level, it will serve as an opportunity to increase understanding.

Hong = If the government has emphasized biosimilars through K-Bio, it seems that there is a need to pay attention to domestic activation in terms of health care policy. If the drug price of the original treatment is lowered in the process of introducing biosimilars, it is not just cost reduction, but it is necessary to consider various incentive systems in terms of patient benefits.

this = In the past, pharmaceutical and biotechnologies presented a vision for development and people at all stages looked at the same standard, but now a detailed approach is needed for each field. In addition to the vaccine sector, if tax benefits and regulations for production and clinical trials are resolved, there will be a more positive effect.

In particular, in order to form a detailed strategy for each stage, the opinions of experts such as professors, doctors, and industries should be asked, and the results of the discussions should be reflected in the policy, so that policies that can actually feel the change should come out.