PLANEGG-MARTINSRIED (dpa-AFX) - The biosimilar manufacturer Formycon is allowed to market its generic version of Eylea from Bayer in the European Union. The European Commission has approved FYB203 under the brand names Ahzantive and Baiama for the treatment of neovascular, age-related macular degeneration (nAMD) and other retinal diseases such as diabetic macular edema (DMÖ), Formycon announced on Monday. This means that the competition for the pharmaceutical and agrochemical company Bayer is growing. Bayer's shares were little changed on Monday morning, while Formycon's recovered by 1.8 percent after the latest setback.
In 2025, patents for the 2-milligram dosage of Eylea will expire in various European countries. However, pharmaceutical companies can secure patents for longer periods with other dosages and similar steps. For example, Bayer had received EU approval for an 8-milligram dosage of Eylea at the beginning of 2024, and the patents for this are likely to be extended. Corresponding applications are pending in the individual countries.
The higher dosage makes it possible to extend the treatment intervals. This should make it more attractive to patients, as Eylea has to be injected directly into the eye.
Bayer generated sales of just over 3.2 billion euros with Eylea in 2023; in the first nine months of 2024, it generated just under 2.5 billion euros, or a good 18 percent of the pharmaceutical division's sales. Continued high sales of the drug are important to Bayer because sales of the anticoagulant Xarelto are plummeting. The patents for the blockbuster drug are gradually expiring.
For Eylea, Bayer holds the license for marketing rights outside the US, where it shares the profits from sales with its partner Regeneron. In the US, Regeneron markets the drug alone./mis/mne/jha/