상위 6개 바이오시밀러 주식 (9월 2026)

특허와 제네릭

The pharmaceutical industry is a business dominated by Intellectual Property (IP). Drug patents are a special category in IP laws, 자체 규정과 기간을 가지고 있습니다, different from general IP rules.

독점성을 보장함으로써, 의약품 특허는 혁신적인 제약 회사가 해당 신약을 유일하게 판매할 수 있게 합니다. 약이 발명된 후 20년이 지나면 특허가 만료되어 제네릭 의약품이 등장할 수 있게 됩니다. 제네릭은 원래 약과 동일한 활성 분자를 사용하지만 다른 어떤 회사에서도 생산할 수 있습니다.

일반적으로 제네릭은 가격을 크게 낮추며, 원래 브랜드의 매출은 제네릭이 시장에 진입할 때 70%~90% 감소합니다.

Generics are rather straightforward, as a drug is a known molecule with a defined formula. So replicating it is rather simple and just a question of setting up the right chemical supply chain.

바이오시밀러

The situation is not so simple for biological medicine, as they are made of much larger and more complex compounds and sometimes entire living cells. So, there is no simple definition of what is a good equivalent of the original treatment. Still, there is an equivalent to generic for biological medicine, which is called biosimilar.

Because of the complexity of manufacturing them, it is impossible to be sure in advance that a biological medicine will be equivalent to another.

For this reason, biosimilars are a lot more complex to develop, 보통 5~9년의 개발 기간과 최대 1억 달러의 연구개발 비용, 그리고 규제 비용이 소요됩니다. This is a massive difference from generic drugs, usually requiring just $1-2M and 2 years to develop.

You can read more about Samsung Bioepis가 제공하는 설명서를 참고하세요.

In 2022, the global biopharmaceutical market was valued at USD 389 billion, which accounts for 30.5% of the entire pharmaceutical market.

Biosimilars represent a subsection of the biopharmaceutical market, worth $16.8B in 2022 and expected to grow to $77B by 2028.

바이오시밀러 기업 비즈니스 모델

Because of the high cost, biosimilar companies differ greatly from generic companies. Generic companies rely on 2 factors for success: low production costs and efficient marketing to replace the established brand drug.

In comparison, Biosimilar has to prove without a doubt that their product is equal in all respects of therapeutic effect, toxicity, half-life, etc. While they can compete on cost, the price difference to the established treatment is less radical, as biological medicines are more costly to produce.

In addition, these treatments tend be for life‑threatening diseases, like genetic diseases or cancer. So, doctors will be reluctant to experiment and change what they know from personal experience.

As a result, biosimilars are a lot more technical and R&D‑driven than generic companies. Their business model relies heavily on a high level of technical expertise in order to produce their treatment at an affordable price and at a constant quality. So, it is quite common to see large, innovative pharmaceutical companies get very active in the biosimilar field.

It also places biosimilars between pure pharma developers and generics. Development is de‑risked as they imitate an existing and approved drug. But it still requires a massive R&D effort and the full 3 phases of clinical trials, even if slightly quicker and cheaper.

This is also a business model with a lot less competitors than generics. Most of these treatments can be in small niches, with only a few thousand patients yearly. So it is not uncommon to see a patent expire, and only 1 or 2 biosimilar companies entering the market, allowing all participants to keep margins relatively high.

상위 6개 바이오시밀러 기업

This list compiles only companies focused in large majority on biosimilars. Other companies have a large biosimilar portfolio, but that activity is diluted by other segments like new drug research, chemical drugs, etc…

(이 주식 목록은 본 기사 작성 시점의 시가총액 기준으로 정렬되었습니다)

1. Samsung Biologics Co., Ltd. (207940.KS)

The company was founded in 2011 and is tied to the wider Korean giant Samsung. It is the world’s largest CMO (Contract Manufacturing Organization) for biopharmaceuticals, with an absolutely massive total production capacity of 364,000 liters.

Since the establishment of the company in 2012, six biosimilars (Remicade, Herceptin, Enbrel, Humira, Avastin, and Lucentis similar) have been released to date and are actively sold throughout the world, including the United States, Europe, Canada, Australia, and Brazil.

출처: Samsung Biologics Q1 2023

In addition, the Company is developing biosimilars for Soliris for blood diseases, waiting for approval. It is also developing a biosimilar for Eylea for eye disease, Prolia for endocrine disease, and Stelara for immune disease, all in phase 3 of clinical trials.

The company has been growing revenues and operating profit quickly since 2020. It expects this pattern to continue with the launch of new biosimilars in the next 1-2 years and the plants being used at full capacity.

출처: Samsung Biologics Q1 2023

Plant number 4, with a 180,000-liter capacity, should be finished by mid-2023. Plant number 5, of 180,000, is also expected to be ready by 2025.

Thanks to its scale and expertise, Samsung Biologics is at an advantage when it comes to manufacturing massive amounts of biosimilars at a competitive price. It is a company that will attract investors looking for a solid growth pattern while also appreciating a very safe profile stemming from both the ongoing profitability and the backing of the Samsung group.

2. Celltrion, Inc. (068270.KS)

Celltrion is another large Korean biosimilar company.

Celltrion created in 2016 the world’s first antibody biosimilar, Remsima, for auto‑immune diseases. It also innovated when developing Remsima, with a hypodermic injection type, which offers a more convenient injection compared to Remsima IV (intravenous injection type)

출처: Celltrion

In total, it commercialized 6 different biosimilars and 9 generic drugs. It has a total production capacity of 190,000 liters, with a total of 450,000 liters planned in the future.

The company is also working on developing a digital healthcare solution. It wants to have a fully‑fledged digital platform for personalized medicine by 2030, based on medical data and AI.

출처: Celltrion

Celltrion net income has been stable in the last 2 years, around $400M. The new facility in construction and the recent approval of hypodermic injection for Remsima should give it some room to keep growing.

Investors will want to stay informed of the company’s plan regarding digital healthcare, as well as the Remsima market and potential new competitors for this drug.

3. Kyowa Kirin Co., Ltd. (KYKOF)

The company is a Japanese biosimilar manufacturer. Its sole product commercialized is Adalimumab, for inflammation/immunology application, sold since 2018.

Being dependent on only one product, the company sales have stagnated since 2018. Management hopes to optimize revenues from Adalimumab, but this is still a work in progress.

The company’s 2025 plan is to expand into 3 other biosimilars.

출처: Kyowa Kirin

The development of the KW‑6356, a potential drug for Parkinson’s, has however been discontinued since the 2025 plan was formulated. This leaves the growth potential mostly on KHK4083 for atopic dermatitis, which entered phase 3 in 2021, especially as this disease affects as many as 16 million people.

출처: Kyowa Kirin

Kyowa Kirin is a successful biosimilar but is in need of new achievements to restart growth and justify its current valuation. A lot relies on KHK4083, and investors in Kyowa Kirin will have to keep a close eye on the end of phase 3 and the commercial results at the potential future launch in 2025‑2026.

4. Viatris Inc.

VTRS 가격 차트

The modern Viatris is the result of the merger between Mylan and Upjohn, a former division of Pfizer (PFE ), in 2020. It is active in various therapeutic areas, with 26 different brands.

출처: Viatris

The company has a rich pipeline of potential new products. This includes complex injectables, with 10 potential drugs and above $1B in annual peak net sales opportunity by 2027.

The company also sees another opportunity above $1B of peak sales by 2028 in 5 other products, of which 3 are already in phase 3 of clinical trials.

출처: Viatris 

Lastly, the company also recently launched an eye division, acquired for $700M, which is projected to add another $1B to net sales by 2028.

출처: Viatris

With revenues at $16.3B in 2022, Viatris has the potential to keep its current earnings and grow them a little in the 2022‑2028 period.

Cash flow has been used to reduce debt, with $3.3B paid back in 2022 (with a free cash flow of 2.55B). With 18.7B of debt left, it would still take Viatris a few years to be debt‑free. Still, considering the free cash flow available, the debt should not endanger the company in any capacity.

Viatris is more fit for investors willing to bet on the company’s continuing success through its development pipeline and recent acquisitions.  They will also bet on a rather low valuation: the P/E ratio is below 6 at the time of writing of this article, following a steady decline in share price since 2018.

5. Shanghai Henlius Biotech, Inc. (2696.HK)

Henlius is a Chinese biosimilar company with a 48,000‑liter manufacturing capacity, with a total capacity aimed at 144,000 liters by 2026.  It currently has 5 marketed products for 18 applications, which brought $298M in revenues in 2022.

Henlius is counting on the biosimilar market of China growing to catch up with the ones of the EU and the USA, with a CAGR of the Chinese market of 175% in the last 3 years.

Henlius currently has 9 candidates in its pipeline.  It will also start to sell more abroad through multiple licensing agreements for a total of $63M.

출처: Henlius

Henlius’s profile is one of aggressive growth and ambitious goals. It is not profitable yet, with $13M of losses in 2022 caused by R&D spending of $141M.

This is a stock for patient investors willing to capitalize on the growth of the Chinese biosimilar market.

If the current plan works, Henlius will more than triple its production capacity and should increase dramatically its revenues, both from more sales of existing products and new additions to the portfolio, as well as some complement from export/licensing agreements.

6. Coherus BioSciences, Inc.

CHRS 가격 차트

Coherus is an American biosimilar company in oncology, immunology, and ophthalmology. It currently has 3 approved products, of which 2 are already marketed. It should launch another 3 in 2023.

출처: Coherus

출처: Coherus

It also aims to have a biosimilar for blockbuster EYLEA in 2025.

The company expects its commercialized products to bring more revenues in 2023, thanks to expanding payer coverage and new key accounts. The new product opportunities are expected to be between $1‑2B, with most coming from YUSIMRY in the $17B inflammation market.

출처: Coherus

Coherus registered a net loss of $292M in 2022 on a total of $211M of revenues. This stemmed from very large spending in 2022, $198M in S&GA (Selling General and Administrative) and $199 in R&D.

Management is planning to reduce the spending by as much as $100M in 2023, having removed 60 employees from its workforce, as it is finishing the work required to approve the new 3 biosimilars expected to reach the market in 2023.

Coherus’s future relies heavily on the success of YUSIMRY’s launch, which will either make it highly profitable or risk the company barely covering its costs. So what is needed is a deeper analysis of the chance the drug will be useful and a good understanding of the other 6 approved biosimilars in the same category.

This makes it an investment for investors willing to take a chance at the approval and commercial success of this YUSIMRY and of the potential growth from the rest of the portfolio.