HOT-3010 (adalimumab biosimilar) / Zhejiang Huahai Pharma, Viropro, Outlook Therap, Ipca Labs, Liomont, Ligand - LARVOL DELTA

Oncobiologics raising $50M for Avastin, Humira biosimilars (MedCityNews) - "New Jersey cancer biosimilar developer Oncobiologics is aggressively pursuing cash: It raised $43 million earlier this year, and is looking for $50 million more, according to a regulatory filing. Oncobiologics...is in the midst of clinical trials to get its Avastin biosimilar approved. It’s readying itself for Phase 3 trials for its Avastin-like biologic. The patents on Avastin are set to expire in 2019...Oncobiologics has another mAb in the clinic – a biosimilar for Humira. This should enter Phase 3 trials next year."

Anticipated new P3 trial • Financing • Patent expiry • Ankylosing Spondylitis • Biosimilar • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

A Randomized, Double-Blind, Multicenter, Equivalence Study of ONS-3010 and Humira for the Treatment of Patients with Moderate to Severe Plaque Psoriasis (clinicaltrialsregister.eu) - P3; N=452; Ongoing; Sponsor: Oncobiologics Limited

New P3 trial • Biosimilar • Immunology • Psoriasis

Oncobiologics: Cantor Fitzgerald Healthcare Conference (Oncobiologics) - "The pharmacokinetic data for Humira and ONS-3010 showed similar profiles over time"; "The results from the immunogenicity showed similar profiles in the three treatment arms"; "The most frequently occurring adverse event (AE) was local administration site irritation-either burning sensation or pain upon injection at the injection site-which was observed less frequently in the ONS-3010 treatment group"

P1 data • Biosimilar

Oncobiologics (ONS) creating a biologic engine as big drug patents expire (Equities) - "Oncobiologics is focused on bringing drugs to market quickly and its Humira® biosimilar is Phase 3 ready...the company also has a manufacturing facility with reduced utility capabilities for a small manufacturing footprint...they estimate the time reduced could go from six months to six weeks."

Anticipated new P3 trial • Ankylosing Spondylitis • Biosimilar • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

ONS-3010: Initiation of P3 trial in 2020 (Oncobiologics) - Q1 FY 2018 Results: Regulatory submission in US in 2021

BLA • New P3 trial • Biosimilar