An aflibercept biosimilar is a biological medication that closely resembles an existing, already approved biologic drug called aflibercept. These biosimilar versions are designed to function in the same way as the original product, offering an alternative treatment option. While not entirely identical to the reference drug, they are proven to have no meaningful differences in their effects on patients.
Understanding Biosimilars
A biosimilar is a type of biologic medicine that is highly similar to a reference biologic product already approved by regulatory bodies like the U.S. Food and Drug Administration (FDA). Unlike generic drugs, which are exact chemical copies of small-molecule drugs, biologics are made from living systems such as cells or microorganisms, making exact replication impossible.
The development of biosimilars involves a rigorous regulatory approval pathway to demonstrate that there are no clinically meaningful differences in terms of safety, purity, and potency compared to the reference product. This extensive evaluation ensures that biosimilars provide the same benefits and risks as the original biologic. The process emphasizes analytical and clinical studies to confirm comparable characteristics and performance.
Aflibercept: The Reference Drug
The original aflibercept drug, marketed under brand names like Eylea, functions as a vascular endothelial growth factor (VEGF) inhibitor. It blocks the activity of certain proteins that promote the growth of abnormal blood vessels and fluid leakage in the eye. Aflibercept binds to VEGF-A and placental growth factor (PlGF), preventing them from interacting with their natural receptors.
This mechanism helps to reduce the growth of new, leaky blood vessels and decrease vascular permeability, which can lead to vision loss. Aflibercept is approved to treat several eye conditions that involve such abnormal blood vessel activity. These include wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). It is administered as an injection directly into the eye.
Therapeutic Applications of Aflibercept Biosimilars
Aflibercept biosimilars are approved for the same therapeutic indications as the original reference product. This means they can be used to treat conditions such as wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. These biosimilars, like Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy), work by inhibiting vascular endothelial growth factor (VEGF) to prevent abnormal blood vessel growth in the eye, similar to the reference drug.
The availability of aflibercept biosimilars expands treatment options for patients suffering from these specific eye conditions. This can lead to increased access to these therapies, particularly for individuals who might face barriers due to the cost of the original biologic. The biosimilars are administered intravitreally, meaning they are injected into the eye, usually as a 2 mg solution, following dosing regimens similar to the reference product.
Safety and Affordability of Aflibercept Biosimilars
Aflibercept biosimilars undergo extensive testing to confirm comparable safety, purity, and potency to the reference product, including analytical, non-clinical, and clinical studies. Clinical trials have shown that aflibercept biosimilars have similar efficacy and safety profiles to the reference product, with no clinically meaningful differences in visual acuity or retinal thickness outcomes. The incidence of adverse events, including ocular side effects, has also been comparable between the biosimilar and the reference drug in studies.
Some aflibercept biosimilars have received an “interchangeable” designation from the FDA, meaning they can be substituted for the reference product by a pharmacist without requiring the prescriber’s direct consultation, depending on state pharmacy laws. This designation is based on robust scientific evidence demonstrating that switching between the biosimilar and the reference product carries no significant risk of diminished efficacy or safety. The introduction of biosimilars fosters competition in the market, which can lead to lower healthcare costs and improve patient access to these important treatments.