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Positive Results of Clinical Trial Comparing Coherus’ Ranibizumab Biosimilar Candidate CHS-201 to Reference Product Lucentis® (Ranibizumab) in the Treatment of Neovascular (Wet) Age-Related Macular Degeneration (nAMD) Presented at Retina Society Annual Scientific Meeting
“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 percent of AMD-related severe visual loss which has a significant deleterious impact on a patient’s quality of life,” said
“CHS-201 is another example of our commitment to bring patients and providers choice without compromise, and, if approved, will enable retinal specialists to make a proven, safe, and essential therapy accessible to more patients with retinal vascular disorders,” said
CHS-201 (also known as FYB201) is being developed as a proposed biosimilar to the reference product, Lucentis® (ranibizumab). In 2019,
About the COLUMBUS-AMD Study
A total of 477 patients with newly diagnosed subfoveal nAMD were randomized 1:1 to receive CHS-201 or reference Lucentis every four weeks for up to 48 weeks. The primary endpoint of the study was change from baseline in best corrected visual acuity (BCVA) measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 8 weeks. Secondary endpoints included change from baseline in BCVA at 48 weeks, change from baseline in FCB retinal thickness at 48 weeks, safety and immunogenicity.
The study results demonstrated a mean BCVA improvement from baseline at eight weeks with an equal median change of 5.0 ETDRS letters for both CHS-201 and Lucentis® treatment groups. The mean change (SD) was 5.1 (7.52) ETDRS letters for CHS-201 and 5.6 (8.63) for Lucentis in the full analysis set population. Analysis of Covariance (ANCOVA) least squares mean difference for the change from baseline in BCVA at week eight between CHS-201 and Lucentis was -0.4 ETDRS letters, with a 90 percent confidence interval of -1.6 to 0.9, well within the predefined equivalence margin of -3.5 to 3.5. Patients in both treatment groups experienced similar reductions in foveal center point (FCP) and foveal central subfield (FCS) retinal thickness, as well as total lesion area. Reduction in the proportion of patients with active CNV leakage and increase in the proportion of patients with a fluid-free macula were similar in both treatment groups. Overall, the frequency and type of ocular adverse events (AEs), including rates of intraocular inflammation, were comparable between the treatment groups. Most AEs were of mild or moderate intensity, and no clinically meaningful differences were identified. CHS-201 and Lucentis had comparable immunogenicity profiles.
Results of the study were published online in
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit
Coherus markets UDENYCA® (pegfilgrastim-cbqv) in
UDENYCA® is a trademark of
Avastin® and Lucentis® are registered trademarks of
Humira® is a registered trademark of AbbVie Inc.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to generate cash flow from its UDENYCA® business; the potential for CHS-201 to gain approval in
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the year ended
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Source: Coherus BioSciences, Inc.