As financial savings and patient benefits, such as health insurance, emerge as major issues 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 major treatments, and endless competition in the global market is predicted in the future. As a result, Europe and the United States are already taking preliminary measures to break down the borders, such as allowing exchanges 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 organized by the Medical Times made it clear that there was no disagreement about the positive function of biosimilars. However, it is noted that there are still many hurdles to overcome 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 (Kyungee University Hospital), Lee Seung-gyu, vice president of the Korea Bio Society, and Kim Tae-hyun, head of Samsung Bioepis’ Korean business. 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 currently evaluate biosimilars?
Head of Headquarters Kim Tae-hyun (hereinafter referred to as Kim)= Treatments released in the early 2000s are undergoing a paradigm shift starting in 2020. From now on, when big popular products are discontinued, 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 protecting the country’s domestic industry that makes original treatments. Looking at the domestic market, demand shows an increase, so we evaluate it positively.
Vice Chairman Lee Seung-gyu (hereinafter referred to as Lee) = In the field of pharmaceuticals, it is difficult for latecomers to catch up and advance in the global market. In this regard, the global competitiveness of domestic companies through biosimilars can have a lot of energy when considered as a whole in the bioindustry.
The biosimilar market is expected to form a market of around 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.
Insurance Director Hong Soong-jae (hereinafter referred to as Hong) = The meaning of the word biosimilar goes beyond the meaning of the same thing (The same) and even the concept of bio bette is emerging. Considering advances in immunology, genetic engineering, and engineering, biosimilars were developed late, but instead, I believe 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 small. In this regard, the biggest impact of the appearance of biosimilars developed by domestic companies is the increase in patient benefits. Beyond just cost, patient discomfort is reflected in the development process, and there are many positive aspects in patient support.
In addition, although I did not think about it when I introduced biosimilar for the first time, I believe that there are many opportunities for patients and doctors, such as developing ideas that emerged in the clinical field through smooth communication, and that there is a positive impact. in terms of 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 technology transfer, clinical, and FDA approval to search for good substances. Currently, at a time when the domestic biopharmaceutical industry continues to invest in global clinical trials and accumulate energy in failure, biosimilars greatly reduce this period.
Kim = Looking at the biopharmaceutical ecosystem, the next 10 years are the turning point and the most important period for expanding the ecosystem. This is because the biosimilar field started with the view that this 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 fixed cash flow prepared by biosimilars will be a hot topic in the future, and I think that the development of new drugs by each company will naturally continue.
Despite the positive evaluation, there is an opinion that the limitations of biosimilars are clear in Korea. What do you think?
Hong = I think it is a matter of experience if the views on biosimilars in the domestic market overlap. New treatments are unfamiliar, and efficacy, safety, and patient preferences are considered, and the same goes for original treatments.
The patient’s question is simple, which 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 as it jumped into development and broke that idea. There are many more countries around the world that cannot do such 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 growing
Kim = As biopharmaceuticals are expensive products, the level of access varies greatly from country to country. As companies are striving to export more with the same momentum as K-Bio in the future, I believe that the ability to expand in the future 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 committed to 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 finance.
Hong = It is good to experience the treatment directly in the clinical process, but if not, you have no choice but to test research data. Since a certain period of time has passed since the introduction of biosimilars, many changes in perception have occurred and doubts have diminished, creating an ecosystem.
The government expects 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 future development of the pharmaceutical industry?
this = When I looked at the cases of companies like Samsung Bioepis and Celltrion, I think it shows 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 global brand.
Kim = In the case of generic development, it costs less than 10 billion won, but biosimilars are at least 100 billion won. As much as that, there is a consensus that companies have a burden on research and development and that they 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 encourage various incentives in societies or academic countries. In a situation where a reduction in the health insurance budget is a hot topic and the share of prescriptions for similar drugs is increasing, it is expected that if drug price incentives or equivalent drugs are announced at government level, it will be 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 regeneration from a health care policy perspective. If the drug price of the original treatment is reduced in the process of introducing biosimilars, it is not just a reduction in costs, but various incentive systems need to be considered in terms of patient benefits.
this = In the past, pharmaceutical and biotech companies presented a vision for development and people looked at each step at the same standard, but now a detailed approach is needed for each area. In addition to the vaccine sector, if tax benefits and regulations for production and clinical trials are resolved, there will be a more positive impact.
In particular, in order to form a detailed strategy for each step, the opinion of experts such as teachers, doctors, and industries should be sought, and the results of the discussions should be reflected in the policy, so that there are policies that can feel real. the change should come out.
