The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for two biosimilars that could expand access for clinicians treating retinal disease and chronic inflammatory conditions: Ranluspec (Lupin Europe GmbH) for wet age-related macular degeneration (AMD) and other retinal disorders, and Gotenfia (Stada Arzneimittel AG) for multiple autoimmune indications. 

Both products now advance toward European Commission approval and, if authorized, are expected to offer lower‑cost alternatives to established originator biologics.

Ranluspec

Ranluspec contains ranibizumab as its active substance and is highly similar to the reference product Lucentis, which was authorized in the European Union in 2007. It is recommended for the full range of VEGF‑A-mediated retinal diseases authorized for the reference product, including wet AMD, diabetic macular edema, proliferative diabetic retinopathy, and macular edema secondary to retinal vein occlusion.

Ranibizumab is a monoclonal antibody fragment that inhibits VEGF-A, a key mediator of angiogenesis. By blocking it, ranibizumab prevents the formation of abnormal blood vessels in the retina, reducing vascular leakage and inflammation, and stabilizing vision in diseases such as wet AMD and diabetic retinopathy.

The approval is based on comprehensive clinical data confirming that Ranluspec demonstrates comparable safety, efficacy, and immunogenicity to Lucentis. It will be available as a 10-mg/mL solution for intravitreal injection and should be administered by ophthalmologists experienced in intravitreal technique.

A phase 3 trial conducted in India with 202 patients confirmed that Ranluspec performed equivalently to Lucentis in terms of visual acuity outcomes, with more than 99% of patients losing fewer than 15 letters on the visual acuity scale.

In a real-world safety analysis, data from 1400 eyes and more than 2000 injections supported the safety profile, with adverse events occurring predominantly as mild and nonserious, such as ocular pain and transient vision blurring. The biosimilar also showed a favorable immunogenicity profile, with 4.95% of patients developing antidrug antibodies compared with 12.87% in the Lucentis group.

The biosimilar offers potential cost savings of approximately 35%-50% compared with Lucentis, which could influence hospital procurement and formulary decisions.

Gotenfia

Gotenfia is a biosimilar to golimumab, which was authorized in the EU in 2009 for treating multiple autoimmune diseases. The CHMP recommended it for the same spectrum of indications as the reference product, including:

• Rheumatoid arthritis (RA): in combination with methotrexate (MTX) for moderate to severe, active RA with inadequate response to disease-modifying antirheumatic drug (DMARDs) or for severe, progressive RA not previously treated with MTX.
• Polyarticular juvenile idiopathic arthritis: in combination with MTX for children 2 years or older with inadequate response to prior MTX therapy.
• Psoriatic arthritis (PsA): alone or with MTX for active, progressive PsA with inadequate response to prior DMARDs.
• Axial spondyloarthritis: severe, active ankylosing spondylitis with inadequate response to conventional therapy, and severe, active nonradiographic axial spondyloarthritis with elevated C-reactive protein (CRP) or MRI signs and inadequate response to nonsteroidal anti-inflammatory drugs.
• Ulcerative colitis (UC): moderately to severely active UC with inadequate response to corticosteroids, 6-mercaptopurine, or azathioprine.

Golimumab is a human immunoglobulin G1 monoclonal antibody targeting TNF-alpha. By binding TNF-alpha, Gotenfia reduces key inflammatory markers, including CRP, interleukin 6, intercellular adhesion molecule 1, matrix metalloproteinase 3, and VEGF. 

Clinical studies confirmed that Gotenfia has equivalent efficacy, safety, and immunogenicity profiles to the originator. The favorable opinion was based on a thorough evaluation of the complete body of evidence, including extensive analytical, nonclinical, and clinical data. It will be available as prefilled syringes in 50-mg and 100-mg doses; treatment must be initiated under the supervision of a qualified healthcare provider.

Both biosimilars demonstrate how the EMA is broadening access to critical therapies through approvals of high-quality, safe, and cost-effective alternatives to originator biologics. Once authorized, the Summary of Product Characteristics, package leaflets, and assessment reports will be published in all official EU languages.