CHS-0214 (etanercept biosimilar) / Coherus Oncology - LARVOL DELTA

A Long Term Safety Extension Study (CHS-0214-05) (clinicaltrials.gov) - P3; N=359; Active, not recruiting; Sponsor: Coherus Biosciences, Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Mar 2017 ➔ Sep 2017

Clinical • Enrollment closed • Trial primary completion date • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Rheumatoid Arthritis • Rheumatology • CRP

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO) (clinicaltrials.gov) - P3; N=521; Completed; Sponsor: Coherus Biosciences, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dermatology • Immunology • Psoriasis • CRP

A Long Term Safety Extension Study (CHS-0214-05) (clinicaltrials.gov) - P3; N=359; Completed; Sponsor: Coherus Biosciences, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dermatology • Inflammatory Arthritis • Psoriasis • Rheumatoid Arthritis • Rheumatology • CRP

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO) (clinicaltrials.gov) - P3; N=496; Recruiting; Sponsor: Coherus Biosciences, Inc.; Trial primary completion date: Mar 2015 ➔ Jul 2015

Clinical • Trial primary completion date • Dermatology • Immunology • Psoriasis • CRP

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO) (clinicaltrials.gov) - P3; N=496; Active, not recruiting; Sponsor: Coherus Biosciences, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Dermatology • Immunology • Psoriasis • CRP

A Long Term Safety Extension Study (CHS-0214-05) (clinicaltrials.gov) - P3; N=400; Not yet recruiting; Sponsor: Coherus Biosciences, Inc.

Clinical • New P3 trial • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Rheumatoid Arthritis • Rheumatology • CRP

A Long Term Safety Extension Study (CHS-0214-05) (clinicaltrials.gov) - P3; N=400; Recruiting; Sponsor: Coherus Biosciences, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Rheumatoid Arthritis • Rheumatology • CRP

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO) (clinicaltrials.gov) - P3; N=424; Not yet recruiting; Sponsor: Coherus Biosciences, Inc.

Clinical • New P3 trial • Dermatology • Immunology • Psoriasis • CRP

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO) (clinicaltrials.gov) - P3; N=424; Recruiting; Sponsor: Coherus Biosciences, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Immunology • Psoriasis • CRP

Baxter strikes up to $246 million deal to develop etanercept biosimilar (Nasdaq) - "Baxter International...struck a deal of up to $246 million with Coherus Biosciences Inc. to develop and commercialize a biosimilar to etanercept for Europe, Canada, Brazil and certain other markets...Under the agreement, Baxter will make an upfront payment of $30 million. Coherus will conduct development and Baxter will make payments of up to $216 million contingent upon the achievement of development and regulatory events."

Licensing / partnership • Biosimilar

CHS-0214-02: Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) (clinicaltrials.gov) - P3; N=647; Completed; Sponsor: Coherus Biosciences, Inc.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Immunology • Rheumatoid Arthritis

Coherus and Baxalta announce CHS-0214 (investigational etanercept biosimilar) met primary efficacy endpoints in phase 3 psoriasis clinical study (RaPsODY) (Coherus Press Release) - P3, N=NA; NCT02134210; Sponsor: Coherus Biosciences; "Coherus BioSciences...and Baxalta Incorporated...today announced that CHS-0214...met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study...the mean percent change in PASI from baseline and the proportion of subjects achieving 75% improvement in PASI from baseline, were within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel®...The study continues as planned until Week 52...Results for the second Phase 3 study in patients with rheumatoid arthritis are expected in the first quarter of 2016."

Anticipated P3 data • P3 data: top line • Biosimilar • Psoriasis

Coherus and Baxalta announce CHS-0214 (investigational etanercept biosimilar) met primary efficacy endpoint in phase 3 rheumatoid arthritis clinical study (RaPsODY) (Coherus Press Release) - P3, N=NA; NCT02115750; Sponsor: Coherus Biosciences, Inc; "Coherus BioSciences...and Baxalta Incorporated...today announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study...primary endpoint was within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel. There were no clinically meaningful differences in the safety and immunogenicity profiles of the two products...'We look forward to advancing this product to registration in various territories in 2016.'"

Anticipated regulatory • P3 data • Biosimilar • Rheumatoid Arthritis

Daiichi Sankyo: Q2 FY 2016 Results (Daiichi Sankyo) - Anticipated regulatory submission in Japan for RA in FY2016

Anticipated Japanese regulatory • Biosimilar

Coherus: Q2 2015 Results (Coherus) - Anticipated regulatory filing in Japan for rheumatoid arthritis and psoriasis in H2 2016

Anticipated Japanese regulatory • Biosimilar

Another skin biotech: Coherus BioSciences files for a $86 million IPO (Nasdaq) - "Coherus BioSciences, which is developing a biosimilar version of Amgen's Enbrel treatment for inflammatory diseases, filed on Thursday with the SEC to raise up to $86 million in an initial public offering."

Financing • Biosimilar • Psoriasis • Rheumatoid Arthritis

Coherus: Annual Report 2014 (Coherus) - Anticipated filing in Japan for rheumatoid arthritis and psoriasis in 2016

Anticipated Japanese regulatory • Biosimilar

CHS-0214: Anticipated approval and launch in Japan for RA in FY2018 (Daiichi Sankyo) - FY2016 Financial Results

Japanese regulatory • Launch Japan • Biosimilar

Coherus: Investor Presentation (Coherus) - Anticipated approval in EU for psoriasis and rheumatoid arthritis in H2 2017

Anticipated EU regulatory • Biosimilar • Psoriasis

Baxalta: Q3 2015 Results (Baxalta) - Anticipated launch in EU for inflammatory diseases in 2017 

Anticipated launch Europe • Biosimilar

Baxter: Investor Conference (Baxter) - Anticipated loss of exclusivity in US in Q4 2028

Commercial • Biosimilar

Coherus BioSciences reports second quarter 2017 corporate highlights and financial results (Coherus Press Release) - "CHS-0214...Focus on US legal and regulatory issues through the first half of 2018...Provide revised guidance on filing of the marketing authorization application in Europe after CHS-1701 U.S. BLA resubmission [end of the fourth quarter of 2017].

Corporate lawsuit • European regulatory • Ankylosing Spondylitis • Biosimilar • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

Coherus: Annual Report 2015 (Coherus) - Anticipated completion of dosing in P3 trial (NCT02115750) for rheumatoid arthritis in April 2016

Enrollment status • Biosimilar

Coherus: Q2 2015 Results (Coherus) - Anticipated topline data from P3 trial (NCT02115750) for RA in Q1 2016; Anticipated topline data from P3 trial (NCT02134210) for psoriasis in Q4 2015

Anticipated P3 data: top line • Biosimilar

Daiichi Sankyo: Q1 FY 2016 Results (Daiichi Sankyo) - "Confirmed bioequivalence btw CHS-0214 and etanercept"; "Efficacy: CHS-0214 met the predefined criteria of equivalency in terms of ACR20 and DAS28-CRP"; "Safety and Immunogenicity: CHS-0214 and etanercept exhibited the same profile"

P3 data • Biosimilar