FDA approves Eylea biosimilar FYB203/AHZANTIVE (aflibercept-mrbb)

On June 28, 2024, Formycon AG, listed on the Frankfurt Stock Exchange (FSE: FYB), and its licensing partner Klinge Biopharma GmbH announced that the U.S. Food and Drug Administration (FDA) has approved FYB203/AHZANTIVE® (aflibercept-mrbb). This biosimilar is designed as an alternative to Eylea® and is intended for the treatment of serious retinal conditions including neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Macular Edema following Retinal Vein Occlusion (RVO).

The FDA's approval of FYB203/AHZANTIVE® is founded on a meticulous review of an extensive dataset encompassing analytical, pre-clinical, clinical, and manufacturing information. The biosimilar demonstrated equivalence in efficacy, safety, pharmacokinetics, and immunogenicity when compared to its reference drug, Eylea®, in patients suffering from neovascular Age-Related Macular Degeneration.

Formycon AG is recognized as a leading developer of biopharmaceutical medicines, particularly biosimilars. The company is dedicated to producing high-quality biopharmaceuticals, aiming to provide more affordable alternatives to existing, high-cost biologics. Formycon AG is publicly traded on the Frankfurt Stock Exchange, reflecting its independent and influential status within the biopharmaceutical industry.

Biosimilars, which are essentially follow-on versions of biopharmaceuticals whose patents have expired, have significantly changed the landscape of treatment for various serious conditions such as cancer, diabetes, and eye diseases since their emergence in the 1980s. These drugs are approved through rigorous regulatory procedures in major markets like the EU, US, Japan, Canada, and Australia. This approval process ensures that biosimilars are highly similar to their reference biopharmaceuticals in terms of efficacy and safety.

The biopharmaceutical industry is at a pivotal moment as many original biotech drugs are approaching the end of their patent protection. By 2025, medications with combined revenues of around USD 100 billion are expected to go off-patent, opening the door for biosimilars to enter the market. Currently, the global sales of biosimilars exceed USD 15 billion, and analysts project that this figure could grow to over USD 74 billion by 2030. This growth is driven by the increasing demand for cost-effective treatment options and the ongoing expiration of patents for original biopharmaceuticals.

The introduction of FYB203/AHZANTIVE® into the market represents a significant milestone not only for Formycon and Klinge Biopharma but also for patients who will now have access to a more affordable treatment option for serious retinal diseases. The approval underscores the potential of biosimilars to provide high-quality, cost-effective alternatives to branded biopharmaceuticals, ultimately benefiting the healthcare system by reducing costs and increasing accessibility to essential treatments.

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