Coherus BioSciences Reaches Clinical and Regulatory Milestones for Udenyca and CHS-201

Coherus BioSciences has reached clinical milestones for 2 of its proposed biosimilar products, an on-body injector (OBI) kit for pegfilgrastim and a biosimilar version of ranibizumab, referencing Lucentis.

The company, based in Redwood City, California, is developing a wearable injector kit for its pegfilgrastim biosimilar (Udenyca) that would compete with Amgen’s commercially successful Onpro device, which holds a 51% share of the market for pegfilgrastim and has enjoyed a tailwind from the COVID-19 pandemic, as it has answered the need for injections delivered outside the clinic.

However, the Onpro's share of the market for pegfilgrastim has declined overall from around 62% of the market in the third quarter of 2018. There are no other OBI pegfilgrastim products on the market aside from Neulasta Onpro.

Coherus BioSciences' pegfilgrastim biosimilar

Pegfilgrastim is used to regenerate white blood cells (neutrophils) following chemotherapy, thereby helping to prevent infection resulting from neutropenia (decreased white blood cell count).

Coherus stated also that positive findings demonstrating safety, efficacy, and immunogenicity equivalence were presented recently for the company’s ranibizumab biosimilar candidate (CHS-201), for the treatment of neovascular age-related macular degeneration (wet AMD). The findings for CHS-201 were presented October 1, 2021, at the 54th Annual Scientific Meeting of the Retina Society.

Investigators in the pivotal COLUMBUS-AMD study sought to determine CHS-201/Lucentis biosimilarity in terms of clinical efficacy, safety, and immunogenicity in patients with newly diagnosed subfoveal wet AMD.

"These findings reinforce our confidence that CHS-201 delivers outcomes and a safety profile similar to the reference product,” stated Peter K. Kaiser, MD, a professor of ophthalmology at the Cole Eye Institute of Cleveland Clinic.

“Neovascular age-related macular degeneration destroys the sharp, central vision needed to see clearly and can affect daily activities like reading, driving, and watching television. It is responsible for more than 90% of AMD-related severe visual loss, which has a significant deleterious impact on a patient’s quality of life,” he said.

Investigators randomized patients (N = 477) equally to CHS-201 or reference product every 4 weeks for up to 48 weeks. The primary end point was the improvement after 8 weeks in best corrected visual acuity (BCVA), as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Secondary end points were BCVA change at 48 weeks and the change in foveal center point (FCP) retinal thickness at 48 weeks.

Patients in the study demonstrated a mean BCVA improvement from baseline at 8 weeks with an equal median improvement of 5 ETDRS letters for CHS-201 (mean [SD], 5.1 [7.52) and the reference product (mean, 5.6 [8.63]) cohorts. Investigators said the BCVA findings for CHS-201 were well within the equivalency margins established for demonstrating biosimilarity.

“Patients in both treatment groups experienced similar reductions in FCP and foveal central subfield retinal thickness, as well as total lesion area,” the investigators said.

They added that proportions of patients from both treatment groups with reduced choroidal neovascularization leakage and increased fluid-free macula also were similar.

The frequency of ocular adverse events (AEs), including intraocular inflammation, were comparable between cohorts, and most AEs were of mild or moderate intensity. The investigators said no clinically meaningful differences were identified. Immunogenicity profiles also were comparable between CHS-201 and the reference product.

On October 1, 2021, the FDA accepted Coherus’ biologics license application for CHS-201 and set a decision date of August 2, 2022. The company said that if approved on schedule, the product would be launched in the second half of 2022.

There is 1 FDA-approved ranibizumab biosimilar so far. Byooviz, a Samsung Bioepis and Biogen product, was approved in September 2021, although a commercial launch is not anticipated before June 2022.

Udenyca OBI

In the trial of the Udenyca OBI, investigators randomized patients (N = 189) equally to OBI followed by prefilled syringe or the reverse.

The company said all pharmacokinetic (PK) bioequivalence primary end points were met, as was the key secondary PK end point of absolute neutrophil count. Investigators said no new safety signals were observed. A 2022 FDA application for marketing approval is planned.

Although the company is seeking FDA approval to market the pegfilgrastim OBI, the Udenyca prefilled syringe was approved in 2018 and launched in January 2019.