Coherus set to refile U.S. application for Neulasta biosimilar, expects approval in H2; shares up 24%

|About: Coherus BioSciences (CHRS)|By:, SA News Editor

Coherus BioSciences (CHRS +23.9%) 2018 guidance. Key points:

Expects to resubmit is U.S. marketing application seeking approval for Neulasta (pegfilgrastim) biosimilar CHS-1701 after receiving the minutes from its meetings with the FDA. It expects commercial launch to commence in H2, dependent of regulatory review and approval timing. In Europe, an opinion by the advisory group CHMP should be rendered in H2. Commercial partnering talks in certain ex-U.S. markets are ongoing.

Clinical development of Lucentis (ranibizumab) biosimilar CHS-3351 will be initiated.

Preclinical development of Eylea (aflibercept) biosimilar CHS-2020 will continue.

Decisions from the U.S. Patent Trial and Appeal Board related to its challenge of two Enbrel (etanercept) patents should be announced next week (CHS-0214).

Anticipates out-licensing global rights to CHS-131, a CNS anti-inflammatory candidate, contingent on the outcome of preclinical studies.

Previously: Coherus restructures after FDA rejects marketing application for Neulasta biosimilar, 30% of workforce axed (June 27, 2017)

Subscribe for full text news in your inbox