– Approved for all eligible indications of the reference biological product, Humira® (adalimumab) –

– YUSIMRY is Coherus’ second FDA-approved product –

REDWOOD CITY, CA, USA I December 20, 2021 I Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) approved YUSIMRY (adalimumab-aqvh), formerly CHS-1420, a Humira® (adalimumab) biosimilar product. YUSIMRY is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.

“We are excited that Coherus has received FDA approval for YUSIMRY, our second approved product, and we are grateful to the patients and investigators who participated in our clinical trials and for the dedication of employees across all functions at Coherus,” said Denny Lanfear, CEO of Coherus. “Growth and diversification of our biosimilar portfolio is a high priority for Coherus — first and foremost as it enables greater patient access to important medicines — and because revenue from these products will fund the continued investment in our innovative pipeline programs that will drive our future growth.”

Approval was based on a comprehensive data package that demonstrated the biosimilarity of YUSIMRY to the reference product, Humira. Data included results from Study CHS-1420-02, a double-blind, randomized, parallel-group, active-control study designed to compare the efficacy and safety (including immunogenicity) of YUSIMRY versus Humira in 545 randomized subjects with moderate to severe chronic plaque psoriasis, and Study CHS-1420-03, a double blind, randomized, single-dose, parallel-group study to confirm pharmacokinetic similarity by comparing the relative bioavailability between YUSIMRY and Humira after a single dose of 40 mg SC administered to over 200 healthy subjects.

“The approval of YUSIMRY brings a new offering to healthcare practitioners and their patients with certain inflammatory diseases,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “We believe high-quality biosimilars provide important alternatives that expand the use of safe and effective medicines to more patients in need. The YUSIMRY approval was supportead by a comprehensive analytical similarity package, as well as comparative pharmacokinetic, efficacy, and immunogenicity studies enrolling patients with moderate to severe chronic plaque psoriasis as well as healthy subjects.”

“YUSIMRY represents an enormous commercial opportunity for Coherus as we continue our mission of increasing patient access to important biologic medicines while at the same time lowering the cost of care,” said Paul Reider, Chief Commercial Officer of Coherus. “Humira is the top-selling drug in the U.S. with 2020 net sales exceeding $16 billion, and demand is high across the healthcare ecosystem for a less expensive Humira biosimilar. We will deliver a compelling value proposition to all stakeholders and look forward to launching YUSIMRY in 2023.”

Coherus plans to launch YUSIMRY in the U.S. on or after July 1, 2023, per the terms of an agreement with Humira® manufacturer, AbbVie.

YUSIMRY™ (adalimumab-aqvh) is a tumor necrosis factor (TNF) blocker indicated to reduce the signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis, and to treat Crohn’s disease, ulcerative colitis and plaque psoriasis. YUSIMRY is a biosimilar of Humira® (adalimumab), which in 2020 was the world’s top-selling prescription drug with global net revenues in excess of $19.8 billion, including U.S. net revenues of $16.1 billion.

YUSIMRY Full Prescribing Information available at www.yusimry.com

About Coherus BioSciences
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 markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta® in the United States, and expects to launch the FDA-approved Humira® biosimilar YUSIMRY™ (adalimumab-aqvh) in the United States in 2023. The FDA is currently reviewing the biologics license application for CHS-201, a biosimilar of Lucentis® (ranibizumab), with a target action date of August 2022. Coherus is also developing CHS-305, a biosimilar of Avastin® (bevacizumab).

Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. In February 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. A biologics license application for toripalimab for the treatment of metastatic or recurrent nasopharyngeal carcinoma is currently under priority review by the FDA with a target action date of April 2022. Toripalimab is also being evaluated in pivotal clinical trials for the treatment of cancers of the lung, breast, liver, skin, kidney, stomach, esophagus, and bladder.

For additional information, please visit www.coherus.com.

SOURCE: Coherus BioSciences