Oncology, Ophthalmology Biosimilars Progress in Europe

As the United Kingdom adds another oncology biosimilar to its collection, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for another ranibizumab candidate.

The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), the nation’s pharmaceutical regulatory agency post-Brexit, approved Celltrion Healthcare’s bevacizumab biosimilar (Vegzelma) for the treatment of various cancers.

According to a report from Korea Biomedical Review, Celltrion received approval for all indications of the reference product (Avastin), including metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and metastatic breast cancer.

The approval comes after the European Commission gave its decision to grant marketing authorization to Vegzelma for the markets within the European Union in August 2022.

Vegzelma marks the third oncology biosimilar developed by Celltrion to be approved in the United Kingdom, following the approvals for Truxima (rituximab) and Herzuma (trastuzumab). Celltrion plans to launch the biosimilar on the UK market “as soon as possible,” and gain approval for Vegzelma in the Republic of Korea and the United States later in 2022.

Additionally, the CHMP gave a thumbs up for STADA Arzneimittel and Xbrane Biopharma’s ranibizumab biosimilar candidate (Ximluci) referencing Lucentis.

Ranibizumab products are used in patients with several retinal conditions including neovascular age-related macular degeneration (wet AMD), diabetic macular edema, diabetic retinopathy, retinal vein occlusion, and visual impairment due to choroidal neovascularization.

The CHMP’s positive opinion will be reviewed by the European Commission, which will decide whether or not to grant marketing authorization for the biosimilar. If approved, Ximluci will become the third ranibizumab biosimilar in the region.

“The positive opinion of the CHMP is a great milestone for Xbrane as it paves the way for approval of our first biosimilar candidate in Europe. We are pleased to be able to make available a more affordable treatment option for patients suffering from these severe eye diseases,” said Martin Åmark, CEO of Xbrane, in a company statement.

The CHMP’s opinion was based on data from a phase 3 clinical study that confirmed comparable safety and efficacy of Ximluci with Lucentis in 580 patients with wet AMD. The primary endpoint of the study was change from baseline to week 8 for best corrected visual acuity, which fell within the predefined equivalence margin.

STADA and Xbrane entered into a commercialization agreement in July 2018. Under the agreement, the 2 companies are both responsible for the development, manufacturing, and obtaining regulatory approval of the product in multiple global markets, including the European Union, the United States, countries in the Middle East and North Africa region, and several markets in the Asia-Pacific region.