September 27, 2021

The SPO recommends against the use of untested biosimilars in Ophthalmology clinical practice.

Communiqué of the Portuguese Society of Ophthalmology

The SPO recommends against the use of untested biosimilars in Ophthalmology clinical practice.

The introduction into clinical practice of anti-VEGF drugs was one of the greatest revolutions in Ophthalmology worldwide. These are drugs that are injected into the vitreous and have significantly reduced the rate of blindness and severe vision loss worldwide over the last decade. They are used in the treatment of several diseases, namely diabetic retinopathy, age macular degeneration, venous occlusions or neovascularisation associated to myopia. In Portugal, Ranibizumab, Aflibercept, Brolucizumab and Bevacizumab (off-label) are being used. All these drugs were tested in international multicentre clinical trials and showed safety and efficacy.

Having learnt that Bevacizumab biosimilars are being considered for use without having been previously tested for their efficacy and safety for intraocular treatment, the SPO expresses its great concern for the safety of patients and RECOMMENDS THE NOT USE OF UNTESTED BIOSIMILARS IN CLINICAL PRACTICE IN OPHTHALMOLOGY.

 

25-09-2021

THE DIRECTION