NI-071 (infliximab biosimilar) / Sanofi, Nichi-Iko, Aprogen, Elea Labs - LARVOL DELTA

GS071: BLA submission in 2019 (Nichi-Iko Pharmaceutical Co., Ltd.) - Q2 FY2017 Results: US approval in FY2020

BLA • Biosimilar

Nichi-Iko: Q2 FY 2015 Results (Nichi-Iko Pharmaceutical Co., Ltd.) - Anticipated approval in Japan for inflammatory diseases in September 2016; Anticipated launch in Japan for inflammatory diseases in November 2016; Anticipated initiation of P1 clinical trial in US for inflammatory disease in early 2016; Anticipated regulatory filing in US for inflammatory diseases in 2018; Anticipated approval in US for inflammatory diseases in 2019

Anticipated BLA • Anticipated Japanese regulatory • Anticipated launch Japan • Anticipated new P1 trial • Biosimilar

Aprogen’s rheumatoid arthritis biosimilar wins sales approval in Japan (Korea Biomedical Review) - "Aprogen Pharmaceuticals said Wednesday that the company’s NI-071 (Original: Remicade), a biosimilar that treats autoimmune diseases, has won a sales approval from Japan’s Ministry of Health, Labour and Welfare....The company also plans to proceed and complete phase 3 clinical trials in the U.S. and apply for sales approval in America next year."

BLA • Japanese regulatory • Trial completion date • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

Nichi-Iko Pharmaceutical to start sales of infliximab BS for I.V. (Reuters) - "Nichi-Iko Pharmaceutical Co Ltd says it will start sales of Infliximab BS for I.V. Infusion 100mg 'Nichi-Iko' on Nov. 29."

Biosimilar launch • Biosimilar

Schnell Life Sciences, Remicade biosimilar phase III clinical trials conducted in Japan (eDaily) - Two phase 3 clinical trials are ongoing in Japan for Remicade biosimilar, developed by Schnell Life Sciences & Ape Rosen; Anticipated approval in Japan by 2015.

Anticipated Japanese regulatory • Trial status • Biosimilar • Rheumatoid Arthritis

A randomized double-blind parallel-group phase III study to compare the efficacy and safety of NI-071 and infliximab reference product in Japanese patients with active rheumatoid arthritis refractory to methotrexate. (PubMed, Mod Rheumatol) - "BS demonstrated equivalent efficacy and safety to RP at treatment weeks 14 and 30, and long-term safety until Week 54 in Japanese RA patients."

Clinical • Journal • P3 data

Korea's 11th unicorn company 'Aprogen' is the only biotechnology company [Google Translation] (Sisaweek) - "...the company has successfully developed 'GS071' (Japan NI071), a biosimilar that is used to treat autoimmune diseases such as rheumatoid arthritis and Crohn's disease...Aprogen plans to apply for the GS071 in the US next year and obtain a US product approval in 2021."

BLA

A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis (RADIANCE) (clinicaltrials.gov) - P3; N=683; Completed; Sponsor: Nichi-Iko Pharmaceutical Co., Ltd.; Active, not recruiting ➔ Completed; Trial primary completion date: Dec 2018 ➔ May 2019

Clinical • Trial completion • Trial primary completion date

Nichi-Iko aims at overseas sales of 60 billion yen in FY2021; Infliximab biosimilar in the US to play key role (Pharma Japan) - "Nichi-Iko Pharmaceutical intends to increase its overseas sales to 60 billion yen in the year ending March 2022, primarily by launching a biosimilar version of Remicade (infliximab) in the US market..."

Sales