Domestic corporations in the biosimilars (biopharmaceutical generic drugs) field are accelerating their entry into the European market for the macular degeneration treatment "Eylea (generic name aflibercept)". This is because the key patent for Eylea is set to expire in Europe this November, while market entry is hindered in the U.S. due to patent litigation.
According to the industry on the 28th, Samsung Bioepis and Celltrion received final approval from the European Medicines Agency (EMA) in November last year and February this year, respectively, and recently, Sam Chun Dang Pharm and Alteogen also received positive recommendations for product approvals from the EMA's Committee for Medicinal Products for Human Use (CHMP).
The CHMP's opinion is the final stage before the authorization, and an official decision is usually made within 2 to 3 months. All four corporations are preparing for commercialization in line with the expiration of the European patent.
Macular degeneration is a disease in which the macula, densely packed with optic nerves in the retina, is damaged due to aging, which can lead to blindness in severe cases. Eylea is a macular degeneration treatment co-developed by the U.S. company Regeneron and Germany's Bayer, with global sales reaching approximately 13 trillion won in 2023. The U.S. market accounts for about 60% of this.
In Korea, as the material patent for Eylea expired in January 2023, Celltrion and Samsung Bioepis have already launched biosimilars. Samsung Bioepis obtained approval from the U.S. Food and Drug Administration (FDA) for its Eylea biosimilar "Ofev" in May this year. Celltrion has applied for FDA approval for "Identzelt" in 2023.
However, both corporations have hit a snag in entering the U.S. market. This is because Regeneron, which holds the U.S. rights to Eylea, filed a patent infringement lawsuit based on the "865 patent". This patent, related to high-concentration injectable formulations, is valid until June 2027. Regeneron continues to argue that the patent applies to the biosimilar formulation.
Samsung Bioepis and Celltrion filed a patent invalidation lawsuit, but the U.S. Court of Appeals dismissed it, stating that they did not sufficiently prove that they did not infringe the patent.
Domestic corporations are in deep thought. If they wait until this patent expires, they could lose the market to competing pharmaceutical companies, including Amgen. Amgen successfully avoided the patent by applying a formulation without a buffer for its Eylea biosimilar "Pavlos".
Domestic companies are seeking an early settlement with Regeneron while focusing on expanding into the European market. A representative from a domestic biosimilar development company noted, "While there is a high risk of patent litigation in the U.S. market and the timing of launch is uncertain, entering the second-largest European market after the U.S. is a realistically favorable situation."