生物技术

Celltrion’s Remsima SC Accelerates Latin American Biosimilar Strategy with Entry into Chile’s Public Market

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Celltrion has achieved another significant milestone in the Latin American biosimilar market. The world’s only subcutaneous infliximab biosimilar, ‘Remsima SC’, has entered Chile’s public market for the first time, marking a critical step in Celltrion’s global strategy. The entry into the public sector, which constitutes 80% of the pharmaceutical market in Latin America, raises expectations for future revenue growth.

Celltrion’s Remsima SC Accelerates Latin American Biosimilar Strategy with Entry into Chile’s Public Market

Unlike the existing intravenous (IV) form of Remsima, Remsima SC is a subcutaneous injection, significantly enhancing patient convenience and healthcare professionals’ work efficiency. Patients who previously had to spend hours receiving IV infusions in hospitals can now conveniently receive treatment at home. This improvement in convenience aligns perfectly with the global trend towards home treatment that has gained traction post-COVID-19.

The success story in Chile highlights the systematic nature of Celltrion’s market entry strategy. After receiving product approval from Chile’s Public Health Institute (ISP) in April 2023, Celltrion has consistently worked for about a year to get listed under public insurance. Notably, the local Inflammatory Bowel Disease (IBD) society chairman submitted a direct request for listing, and patient associations actively voiced their support, demonstrating the clinical value of the product being well-recognized by local medical professionals and patients.

What stands out is the competitiveness of Remsima SC as evidenced during the evaluation process by Chilean regulatory authorities. Among approximately ten drugs under review for new drug listing, Remsima SC was the only one successfully listed, indicating high evaluations of its safety, efficacy, and cost-effectiveness. The global data validated in Europe and North America proved effective in the Latin American market, reflecting Celltrion’s efforts in quality management and adherence to global standards.

Structural Characteristics and Opportunities in the Latin American Biosimilar Market

Understanding the structure of the Latin American pharmaceutical market clarifies why the entry into Chile’s public market is so crucial. With a public-to-private market ratio of 8:2, the public market essentially drives revenue. This market structure differs from major developed countries in North America or Europe, where the government-led health insurance system is more developed, making public insurance listing directly linked to market share.

The growth potential for biosimilars in the autoimmune disease treatment market is particularly significant. Following the patent expiration of the original drug Remicade (infliximab), the global biosimilar market has been rapidly expanding. The global infliximab market is estimated to be around $6 billion by 2024, with the share of biosimilars increasing annually. In Latin America, where biosimilar adoption has been relatively slow, the growth potential is expected to be even greater.

Celltrion’s competitive edge lies in the fact that Remsima SC is the world’s only subcutaneous infliximab biosimilar. Competitors like Pfizer’s Inflectra and Johnson & Johnson’s Remicade are only available in intravenous form, giving Remsima SC a clear differentiation point in terms of patient convenience. This is seen as an innovation that transforms the treatment paradigm beyond mere price competition.

Market data further clarifies the value of this differentiation. After the launch of Remsima SC in Europe, it showed about 30% faster market penetration compared to the existing intravenous form, and over 90% of patients in satisfaction surveys expressed a preference for the subcutaneous form. Healthcare professionals also favor it as it reduces the burden on hospital infrastructure and allows for more efficient patient treatment.

Global Biosimilar Competition and Celltrion’s Positioning

In the global biosimilar market, Celltrion currently maintains a position within the top three in terms of revenue. Novartis’ Sandoz division holds the first position, followed by Pfizer. Celltrion is the undisputed leader among Asian companies. As of 2024, Celltrion’s biosimilar revenue is estimated to exceed 2 trillion won, with the Remsima product line accounting for about 60% of that.

Compared to competitors, Celltrion’s strengths are more pronounced. Pfizer’s Inflectra, launched in 2016, currently records annual sales of about $2 billion but is only available in intravenous form. Amgen’s Avsola is in a similar situation. In contrast, Celltrion offers both Remsima IV and Remsima SC, catering to diverse needs of patients and healthcare professionals with a comprehensive portfolio.

In the Latin American market, Celltrion has already established a substantial foundation. Existing products like Remsima IV, Truxima (rituximab biosimilar), Herzuma (trastuzumab biosimilar), and Yuflyma (adalimumab biosimilar) are all supplied to Chile’s public market, creating an environment to maximize synergy between products. This enables much more efficient marketing and sales activities than a single product entry.

Brazil’s market entry is also noteworthy. In September this year, Remsima SC was listed in Brazil’s public market, the largest pharmaceutical market in Latin America. Brazil accounts for about 40% of the entire Latin American pharmaceutical market. Brazil’s public healthcare system, SUS (Sistema Único de Saúde), covers approximately 210 million people, making it one of the world’s largest public healthcare systems. Success here is expected to have a decisive impact on Celltrion’s Latin American strategy.

From a financial perspective, entry into the Latin American market plays a crucial role in diversifying Celltrion’s revenue and securing growth drivers. As of the third quarter of 2024, Celltrion’s overseas revenue accounts for about 75% of the total, with Europe having the largest share. However, as the share of emerging markets like Latin America gradually increases, the balance of regional revenue is improving.

Industry experts predict that Celltrion’s Latin American strategy will yield significant results in the long term. The market growth rate is expected to exceed an annual average of 15%, driven by economic growth, improvement in medical infrastructure, and increased awareness of biosimilars in the Latin American region. In particular, with the rising incidence of autoimmune diseases, demand for innovative treatment options like Remsima SC is expected to continue growing.

It will be fascinating to see what achievements Celltrion will make in Latin America. If the success in Chile and Brazil extends to other major countries like Argentina, Colombia, and Peru, Latin America could become a key market following Europe. Most importantly, it is impressive to see the company achieving growth while providing better treatment options for patients.

#Celltrion #SamsungBiologics #YuhanCorporation #Johnson & Johnson #AbbVie


This article was written after reading the Celltrion, First Sale of ‘Remsima SC’ in Chile’s Public Market in Latin America article, adding personal opinions and analysis.

Disclaimer: This blog is not a news outlet, and the content reflects the author’s personal views. Investment decisions are the responsibility of the investor, and the author assumes no responsibility for any investment losses based on this article.

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