BOW050 (adalimumab biosimilar) / Epirus - LARVOL DELTA

Biologics for Crohn's Go Head to Head (MedPageToday) - '"As the number of therapeutic options for Crohn's disease grows, rigorous evidence from direct comparisons in blinded, randomized controlled trials such as SEAVUE are becoming increasingly important in selecting the right treatments for our patients,' said Sands."

Media quote

Epirus Biopharmaceuticals reports third quarter 2015 financial results & provides business update (Epirus Press Release) - "EPIRUS Biopharmaceuticals...today reported financial results for the third quarter of 2015, and provided a business update...Completed regulatory submissions for marketing authorization of BOW015 (Infliximab) in multiple countries in Southeast Asia, including Malaysia, Thailand and Indonesia...global filing anticipated in 2017 for marketing approval in Europe, US and Canada."; Anticipated global filing for: BOW050 in 2018, BOW070 in 2019, BOW080 in 2020, BOW090 in 2021 and BOW100 in 2022.

Anticipated BLA • Anticipated Canadian regulatory • Anticipated EU regulatory • Non-US regulatory • Biosimilar

Epirus: Q3 2015 Results (Epirus Biopharmaceuticals) - Anticipated harmonized global filing for inflammatory diseases in 2018

Anticipated regulatory • Biosimilar