AMCP Corporate Member Spotlight: Coherus BioSciences
AMCP News & Views recently caught up with Vinson Lee, PharmD, MS, FCPhA, FAMCP, vice president of Coherus BioSciences to learn about his company and gain insights on becoming an AMCP Corporate Member.
As you considered becoming a Corporate Member, what tipped the scales?
Coherus BioSciences is focused on expanding patient access to important, cost-effective medicines and delivering significant savings to the U.S. health care system. Every member of the Coherus team is dedicated, motivated, and passionate about expanding patient access to lifesaving therapeutics. Our colleagues are experts in analytical and process sciences, deeply experienced in clinical development and regulatory affairs, and have proven commercial and marketing capabilities. Everyone at Coherus is committed to meeting the highest standards, inspiring our teammates, and achieving our goals.
We believe that our focus is closely aligned with AMCP’s mission to improve patient health by ensuring access to high-quality, cost-effective medications and other therapies and AMCP’s strategic priority to optimize value and access by addressing barriers to access, care, and affordability. Becoming an AMCP Corporate Member is important to further the common goal of ensuring positive health care outcomes through quality, accessible, and affordable pharmaceutical care for the patients we serve.
What is your strategy and anticipated innovations for 2022?
Coherus BioSciences is a commercial-stage biopharmaceutical company focused on the research, development, and commercialization of innovative immunotherapies to treat cancer. Our strategy is to build a leading immuno-oncology franchise funded through net sales of our diversified portfolio of FDA-approved therapeutics.
We in-licensed our lead immuno-oncology product candidate, toripalimab (CHS-007), a novel anti-PD-1 antibody, from Shanghai Junshi Biosciences Co., Ltd. in February 2021. The FDA has granted Priority Review for the toripalimab BLA, as well as Breakthrough Therapy Designation for toripalimab for the treatment of nasopharyngeal carcinoma (“NPC”) and set a Prescription Drug User Fee Act (PDUFA) action date for April 30, 2022. Toripalimab is being evaluated in late-stage clinical trials for the treatment of a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. Within the next several years, if toripalimab is approved, we anticipate submitting BLA supplements for multiple additional cancer indications.
In January 2022, we initiated the process to exercise the option to license JS006, the TIGIT-targeted antibody, in the United States and Canada. Antibodies blocking TIGIT (T cell immunoglobulin and ITIM domain) have shown potential for enhanced anti-tumor activity in combination with PD-1/PD-L1 inhibitors. In preclinical studies, JS006 demonstrated strong binding affinity and inhibition of the TIGIT pathway. The FDA has cleared an investigational new drug application (IND) allowing clinical trials of JS006 in the United States, and we plan to advance toripalimab in combination with JS006 in a clinical trial in North America later in 2022.
We are also developing an internal immuno-oncology pipeline leveraging our demonstrated expertise in preclinical and translational science, bioinformatics, analytical characterization, process science engineering, and clinical-regulatory development and commercialization. Our preclinical pipeline includes antibodies that are designed to address immune suppression in the tumor micro-environment, enhance the anti-tumor activity of toripalimab and potentially improve clinical benefit for cancer patients. We expect to submit an IND to the FDA for the first of these programs in 2023.
What’s your one-minute elevator speech about your company?
Coherus BioSciences has built an experienced and robust oncology market access, key account management and medical affairs capability in the United States, supporting the successful commercialization of UDENYCA® (pegfilgrastim-cbqv). We expect to leverage these capabilities as we build and launch our immuno-oncology franchise.
The Coherus portfolio includes two FDA-approved biologics. Our first product, UDENYCA® (pegfilgrastim-cbqv), a biosimilar to Neulasta®, a long-acting granulocyte-colony stimulating factor, was launched commercially in the United States in January 2019. In December 2021, the FDA-approved YUSIMRY™ (adalimumab-aqvh), formerly CHS-1420, our Humira® (adalimumab) biosimilar product, which we plan to launch in the United States on or after July 1, 2023, per the terms of an agreement with Humira manufacturer, AbbVie Inc. In addition to our two FDA-approved biologics, we also have two additional product candidates in the late stage of review with the FDA, toripalimab and CIMERLI™ (ranibizumab-ranq injection), a Lucentis® (ranibizumab) biosimilar candidate. The PDUFA action date for the toripalimab BLA is April 30, 2022. In 2021, our partner, Bioeq, submitted to the FDA a BLA for CIMERLI. The FDA has accepted the application for filing and set a target action date of August 2022.
Learn more about becoming an AMCP Corporate Member.
