FDA clears path for Aflibercept Biosimilars in macular degeneration therapy

As per the FDA’s press release, Aflibercept-jbvf and Aflibercept-yszy biosimilars have been approved as interchangeable biosimilars to Aflibercept, ensuring comparable safety and effectiveness for patients to treat various eye conditions.

These biosimilars block VEGF to prevent abnormal blood vessel growth in the eye and reduce damage to the retina, helping to preserve vision. They are administered intravitreally at a dosage of 2 mg to address conditions including exudative macular degeneration, macular edema due to retinal vein blockage, diabetes-related macular edema and retinopathy.

This approval is based on the comprehensive evaluation of scientific evidence demonstrating similarity to Aflibercept with no clinically meaningful differences from Aflibercept. This evaluation included extensive analytical tests, biological assays, and comparative clinical studies with Aflibercept.

In terms of safety, the safety profiles of the approved biosimilars and Aflibercept are similar. Conjunctival haemorrhage, eye pain, cataracts, vitreous detachment, floaters and increased eye pressure are some of the commonly encountered side effects (incidence of more than equal to 5%). Caution needs to be exercised in case of allergies, inflammation in the eye, increased eye pressure, or risk factors for blood clots.