Positive results of clinical trial comparing Coherus CHS-201 biosimilar ranibizumab to reference product Lucentis® (Ranibizumab) in the treatment of neovascular (wet) age-related macular degeneration (nAMD) presented at the meeting Retina Society Annual Scientist
REDWOOD CITY, Calif., October 04, 2021 (GLOBE NEWSWIRE) – Coherus BioSciences, Inc. (âCoherusâ, Nasdaq: CHRS) today announced that positive results from the pivotal COLUMBUS-AMD clinical trial evaluating and comparing the efficacy and safety between CHS-201 and LucentisÂ® (ranibizumab) in the treatment of age-related neovascular (wet) macular degeneration (nDMA) was presented on October 1st by Dr Peter K. Kaiser, professor of ophthalmology at the Cole Eye Institute at the Cleveland Clinic, at 54e Retina Society Annual Scientific Meeting. The COLUMBUS-AMD study demonstrated the similarity of CHS-201 and the Lucentis reference product in terms of clinical efficacy, safety and immunogenicity in patients with newly diagnosed subfoveal nAMD.
âAge-related neovascular macular degeneration destroys the sharp central vision needed to see clearly and can affect daily activities such as reading, driving and watching television. It is responsible for over 90 percent of severe visual loss associated with AMD, which has a significant deleterious impact on a patient’s quality of life, âsaid Dr. Kaiser. âThese results reinforce our confidence that CHS-201 offers results and a safety profile similar to those of the reference product. “
“CHS-201 is another example of our commitment to providing patients and providers with uncompromising choice and, if approved, will enable retinal specialists to make proven, safe and essential treatment available to a greater large number of patients with retinal vascular disorders, âsaid Denny Lanfear, CEO of Coherus.
CHS-201 (also known as FYB201) is under development as a proposed biosimilar to the reference product, LucentisÂ® (ranibizumab). In 2019, Coherus BioSciences acquired the exclusive rights to Bioeq AG, a Swiss biopharmaceutical joint venture between the StrÃ¼ngmann group and the Polpharma Biologics group, to market CHS-201 in the United States. In August 2021, Bioeq submitted the Biologics License Application (BLA) CHS-201 to the United States Food and Drug Administration (FDA). The FDA accepted the BLA dossier for review and set a target action date of August 2, 2022. If approved, Coherus plans to begin marketing CHS-201 in the United States in the second half of 2022.
About the COLUMBUS-AMD Study
A total of 477 patients with newly diagnosed subfoveal AMD 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 the change from baseline for best corrected visual acuity (BCVA) measured by letters from the Diabetic Retinopathy Early Treatment Study (ETDRS) after 8 weeks. Secondary endpoints included change from baseline of BCVA at 48 weeks, change from baseline in retinal thickness of FCB at 48 weeks, safety and immunogenicity .
Study results demonstrated a mean improvement in BCVA from baseline at eight weeks with an equal median change of 5.0 ETDRS letters for the CHS-201 and LucentisÂ® 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 entire analysis population. The mean analysis of covariance (ANCOVA) least squares difference for change from baseline in BCVA at week eight between CHS-201 and Lucentis was -0.4 ETDRS letters, with an interval 90% confidence of -1.6 to 0.9, well within the preset equivalence range of -3.5 to 3.5. Patients in both treatment groups experienced similar reductions in foveal central point (FCP) and foveal central subfield (FCS) retinal thickness, as well as total lesion area. The reduction in the proportion of patients with active CNV leakage and the increase in the proportion of patients with fluidless macula were similar in the two treatment groups. Overall, the frequency and type of ocular adverse events (AEs), including rates of intraocular inflammation, were comparable between treatment groups. Most AEs were mild or moderate, and no clinically significant difference was identified. CHS-201 and Lucentis had comparable immunogenicity profiles.
Study results have been published in line in May 2021 in Ophthalmology.
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company whose mission is to increase access to cost-effective medicines that can have a major impact on the lives of patients and deliver significant savings to the healthcare system. Coherus’ strategy is to build a leading immuno-oncology franchise funded by cash generated from its biosimilars business. For more information, please visit
Coherus markets UDENYCAÂ® (pegfilgrastim-cbqv) in the United States and plans to launch toripalimab, an anti-PD-1 antibody by 2023, as well as biosimilars of LucentisÂ®, HumiraÂ® and AvastinÂ®, if they are approved.
UDENYCAÂ® is a trademark of Coherus BioSciences, Inc.
AvastinÂ® and LucentisÂ® are registered trademarks of Genentech, Inc.
HumiraÂ® is a registered trademark of AbbVie Inc.
Except for 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. to be limited thereto, the ability to generate cash flow from its UDENYCAÂ® activity; the possibility of CHS-201 being approved in the United States; the potential for Coherus to launch CHS-201 in the United States in the second half of 2022; the possibility for Coherus to gain approval for other biosimilars in the United States; Coherus plans to invest cash generated from its biosimilar business to build a franchise specializing in immuno-oncology; Ability of Coherus to prepare for the planned launches until 2023 of toripalimab and the biosimilars of HumiraÂ®, AvastinÂ® and LucentisÂ®, if approved.
These forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ materially from future results, performance or achievements expressed or implied by the forward-looking statements. These 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 may not be able 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 assumes no obligation to update or revise any forward-looking statements. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Coherus ‘business in general, see Coherus’ annual report on Form 10-K for for the fiscal year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021, its quarterly report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our results of operations for future periods.
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