Competition among domestic and international pharmaceutical corporations regarding the treatment market for macular degeneration is intensifying.
According to the industry on the 30th, the price of the macular degeneration and diabetic macular edema treatment ‘Amelivu Injection 10 mg,’ developed and produced by Samsung Bioepis and distributed by Samil Pharmaceutical, will be reduced to 150,000 won effective June 1.
Amelivu is a biosimilar of the original drug ‘Lucentis’ (ingredient name ranibizumab) developed by Genentech. When first listed in January 2023, the price of this treatment was 463,773 won. It was subsequently reduced to 350,000 won in March of that year, and the price has been lowered again this year.
Samsung Bioepis’s decision to lower prices this time is interpreted as a response to the prices of competitors' products. Chong Kun Dang also launched the Lucentis biosimilar ‘LucenBS Injection’ in 2023, targeting the market with competitive pricing from the beginning. The initial listing price for LucenBS at 10 mg in January 2023 was 300,000 won, which was lowered to 150,000 won in February of last year.
With Samsung Bioepis lowering the price of Amelivu, the two companies' products will now compete at the same price in the market. Industry insiders expect that marketing competition between the two companies will become increasingly fierce in the latter half of this year.
Chong Kun Dang stated that there has been no discussion about further price cuts for LucenBS at this time. A company representative noted, ‘LucenBS was released in the domestic market first and has been building its position by focusing on price competitiveness,’ adding that it plans to enhance its marketing strategy to secure competitiveness.
The original drug Lucentis was developed by Genentech in the U.S. and sold by Swiss Roche and Novartis. Before the biosimilar came to market, it generated global annual sales of 4 trillion won in 2022. The original price of Roche and Novartis’s Lucentis at 10 mg was about 820,000 won, but following the launch of biosimilars, the price dropped to around 570,000 won.
According to the market research organization IQVIA, the domestic macular degeneration treatment market was valued at 126.3 billion won as of 2022 and is expected to grow by an average of over 10% annually, reaching approximately 200 billion won by 2030. The number of domestic macular degeneration patients, which was 200,471 in 2019, increased to 497,338 in 2023, nearly a 2.5-fold rise over the past five years.
The global market is also expected to experience growth. According to the market research agency GlobalData, the global macular degeneration treatment market is projected to expand from $7.4 billion (approximately 10 trillion won) in 2021 to $27.5 billion (approximately 37 trillion won) by 2031.
Biosimilars have disrupted the macular degeneration treatment market, which has been monopolized by a few original drugs. Recently, with the expiration of the patent for Regeneron and Bayer’s macular degeneration treatment ‘Eylea’ (ingredient name aflibercept) approaching, competition for the development and release of biosimilars has intensified.
Last year, Eylea biosimilars such as Celltrion’s Eydenzelt (CT-P42), Samsung Bioepis’s Afilivu (SB15), and Amgen’s Pavblu received approvals from the U.S. Food and Drug Administration. Alteogen’s ALT-L9 and Sam Chun Dang Pharm’s SCD411 have also completed global phase 3 trials and are currently seeking approval in Korea and Europe.
However, the U.S. release, the world’s largest pharmaceutical market, has hit a snag. Although the patent for Eylea in the U.S. expired last year, Regeneron and Bayer have filed lawsuits against biosimilar developers, blocking the U.S. launch. They have pursued an ‘evergreen strategy’ by filing various types of patents related to formulation and administration methods in preparation for the expiration of the Eylea patent.