The European Medicines Agency (EMA) has announced its approval of two new biosimilar medications, Afqlir and Opuviz, to treat age-related macular degeneration (ARMD). The active ingredient of both agents is aflibercept, already used in the similar medication Eylea, authorized in 2012.
At a meeting of the Committee for Medicinal Products for Human Use (CHMP), both Afqlir and Opuviz received an identical positive opinion recommending granting marketing authorization for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema secondary to branch or central retinal vein occlusion, visual impairment due to diabetic macular edema, and visual impairment due to myopic choroidal neovascularization.
However, the CHMP confirmed its refusal of a marketing authorization for Syfovre (pegcetacoplan) to treat geographic atrophy secondary to ARMD.
Comparable With Eylea
The EMA said that both Afqlir and Opuviz had quality, safety, and efficacy comparable with Eylea, which had been used as the reference product. Both new drugs will be available as a 40-mg/mL solution for injection. Both authorizations stipulate that the agent must be administered by a qualified physician experienced in giving intravitreal injections.
Detailed recommendations for their use will be included in the summary of product characteristics, which will be published in the European public assessment report after the marketing authorization has been granted by the European Commission.
Aflibercept is a recombinant fusion protein developed as an antineovascularization agent. It consists of the extracellular domains of human vascular endothelial growth factor (VEGF) receptor 1 and 2 fused to the Fc portion of human immunoglobulin G1. By acting as a soluble decoy for natural VEGF receptors, aflibercept inhibits their activation, thereby reducing angiogenesis.
What Are Biosimilars?
Biosimilars are medicines highly similar in all essential aspects to an already approved biological medicine. An increasing number of such medicines have been approved through an EU-pioneered regulation framework enabling comparison with a reference medicine already approved in the EU — in this case, Eylea.
By demonstrating biosimilarity, a biosimilar can rely on the safety and efficacy experience gained with the reference medicine, avoiding unnecessary repetition of clinical trials. This requires that extrapolation from the reference product is supported by all the scientific evidence generated in comparability studies (quality, nonclinical, and clinical). The aim is to improve patient access to safe and effective biological medicines with proven quality. Monitoring by the EU over the past decade has not identified any relevant difference in the nature, severity, or frequency of adverse effects between biosimilars and their reference medicines.
The recommended dose for Eylea is 2 mg aflibercept, equivalent to 0.05 mL. The drug is initiated with one injection per month for three consecutive doses. After this, the treatment interval is extended to 2 months and may be maintained or further extended on the basis of the treating clinician’s judgment to maintain stable visual and/or anatomic outcomes. If outcomes deteriorate, the treatment interval should be shortened accordingly.
Second Refusal of Authorization for Syfovre
The CHMP also noted that after a reexamination, it was confirming its initial recommendation to refuse the granting of a marketing authorization for Syfovre (an ophthalmic formulation of pegcetacoplan) for the treatment of geographic atrophy secondary to ARMD. The EMA said that more information would be published shortly.
