NewsView printer-friendly version
Coherus Announces BLA Filing for Lucentis® (ranibizumab) Biosimilar Candidate Accepted by FDA for Review
- FDA has set a target action date of
August 2, 2022for the CHS-201 BLA
“We are gratified that the CHS-201 BLA was accepted for review as it represents yet another milestone on our mission to expand access to important medicines while delivering substantial savings to the
In addition to CHS-201, Coherus’ biosimilar portfolio includes UDENYCA® (pegfilgrastim-cbqv), which the Company launched 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 www.coherus.com.
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
Coherus Contact Information:
+1 (949) 903-4750
Source: Coherus BioSciences, Inc.