On August 2, the Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), which demonstrated efficacy and safety results parallel to its reference product, Roche’s Lucentis (ranibizumab). This approval is of paramount interest as Cimerli is the first anti-VEGF biosimilar in the Diabetic Macular Edema (DME) space to gain a 12-month interchangeability exclusivity with Lucentis, says GlobalData, a leading data and analytics company.

In Phase III trial COLUMBUS-AMD (NCT02611778), Cimerli was evaluated against Lucentis in patients with neovascular (wet) age-related macular degeneration (AMD) for eight weeks; the former 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 over 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 lead to its approval, and prospective launch in October 2022.

Sara Reci, Pharma Analyst at GlobalData, comments: “Lucentis was the first anti-VEGF inhibitor therapy to be approved for DME, with first-to-market advantage, thus the biosimilar market for this therapy is in a highly competitive stage; currently, there are 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.”

Furthermore, KOLs interviewed by GlobalData expressed their impartiality regarding the use of biosimilars. While they do agree that biosimilars provide a cheaper alternative treatment to their reference products, many are sceptical 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.

Reci continues: “While Cimerli has only undergone Phase III Clinical trials for wAMD, it has been granted approval for four other ophthalmic indications including DME, diabetic retinopathy (DR), myopic choroidal neovascularization (mCNV), and macular edema following retinal vein occlusion (RVO), for which there are no late-stage clinical trials, bypassing the essential steps that are usually taken for biologics”

Nevertheless, 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 highly anticipated Roche’s Vabysmo. It is also helpful where insurance status is an issue, which is an increasingly common factor in the US. Furthermore, for doctors who do use Lucentis, there will be added pressure from payers to switch to Cimerli with its direct interchangeability with Lucentis approved.

Reci concludes: “As the only anti-VEGF inhibitor biosimilar within the DME space that has interchangeability exclusivity with Lucentis, Cimerli holds a huge competitive advantage that sets it apart from all other biosimilars in the DME space, all while simultaneously establishing itself across multiple other retinal disease markets.”