FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. Cimerli is a biosimilar of Lucentis (ranibizumab) and has been granted 12 months of interchangeability exclusivity across five different retinal diseases: DME, diabetic retinopathy (DR), neovascular (wet) age-related macular degeneration (AMD), myopic choroidal neovascularisation (mCNV), and macular oedema following retinal vein occlusion (RVO). DME, a leading cause of blindness among diabetic patients, is primarily treated by VEGF inhibitor therapies. 

In COLUMBUS-AMD, Cimerli’s Phase III study in patients with AMD (NCT02611778), after eight weeks, Cimerli demonstrated a mean improvement in best corrected visual acuity (BCVA) of 5.1 early treatment diabetic retinopathy study (ETDRS) letters, in comparison to its reference, Lucentis, which had an improvement of 5.6 ETDRS letters. Thus, the biosimilar presented a similar efficacy to the reference product. With respect to its safety profile, Cimerli had more than 3% fewer adverse events (AEs) than Lucentis; however, there were no clinically relevant differences for safety. All in all, following rigorous testing procedures, results for the safety and efficacy of Cimerli were highly promising, meeting the FDA’s meticulous standards, which ultimately led to its approval and prospective launch in October this year. 

Cimerli’s biosimilar status is appealing to providers and patients alike in the US. Biosimilars typically have a cheaper price point; this will help to increase treatment access, especially in cases where step therapy may be required as a pre-requisite to the gold standard, Bayer’s Eylea (aflibercept), and Roche’s highly anticipated Vabysmo. It is also helpful where insurance status is an issue, which is an increasingly common factor in the US. In addition, for doctors who do use Lucentis, there will be added pressure from payers to switch to Cimerli with its direct interchangeability with Lucentis approved. 

Lucentis was the first anti-VEGF inhibitor therapy to be approved for DME, with a first-to-market advantage, meaning the biosimilar market for this therapy is in a highly competitive stage. There are currently two other ranibizumab biosimilars in the late-stage pipeline: Byooviz and Xlucane. Despite this, the success of Lucentis and its biosimilars is dominated by Eylea, which is widely accepted as the gold-standard anti-VEGF treatment for DME. Key opinion leaders (KOLs) have stressed that despite biosimilars becoming available for ranibizumab, the anticipated launch of an aflibercept biosimilar, which is also currently in the late-stage pipeline, will follow its reference product and therefore may also outshine ranibizumab biosimilars. 

Despite Cimerli’s approval, KOL opinions on biosimilars remain impartial. While they do agree that biosimilars provide a cheaper alternative treatment to their reference products, many are skeptical of using them since biosimilars are validated with far fewer studies and for far fewer indications in comparison to their reference drug prior to reaching the market—as is the case for Cimerli, which has been approved for DME among other indications, despite not having undergone clinical trials for DME before reaching the market. Nonetheless, as the only DME biosimilar with interchangeability exclusivity with Lucentis, Cimerli does have a huge advantage that sets it apart from all other biosimilars in the DME space.