Biologics are naturally sourced molecules engineered to target specific pathways in many inflammatory and autoimmune disorders. In the last decade, there has been an increased interest in the development of biologics in the treatment of inflammatory diseases (typically but not always rheumatologic conditions). Anti-VEGFs, given intravitreally, are increasingly being utilized in ocular indications including age-related macular degeneration and diabetic retinopathy. These biologics have significant clinical benefits, including gain of vision, but may come at a high financial cost. Importantly, the emergence of biosimilars is expected to play a key role in lowering healthcare costs and improving patient access. As a step towards improved patient access and decreased burden to the healthcare sector, the EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines approved in the EU are interchangeable not only with their reference medicine, but also with an equivalent biosimilar. In 2022, the FDA has also shown a positive stance towards biosimilar approvals with recent biosimilars being approved without ‘switching’ studies.

What are your perceptions of the efficacy and safety of ocular biosimilars? What are the barriers or challenges faced by biosimilars and their uptake?