Biosimilars Update: Clinical Trials, Marketing Authorization Applications, Licenses, and Launches

Today, we’re catching up with news from around the industry.

Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710.  According to the announcement, the study, a randomized, double-blind trial of 558 patients over 22 weeks, demonstrated the non-inferiority of ABP 710 to infliximab on efficacy and safety endpoints in patients with moderate-to-severe rheumatoid arthritis.

BIOCAD announced that its rituximab biosimilar was approved by the Department of Health of the Republic of Cuba.  According to BIOCAD, the first supplies of its rituximab biosimilar are scheduled to reach the Cuban market in late 2018.

LG Chem reportedly launched its Enbrel (entanercept) biosimilar, Eucept, in Korea.  As we previously reported, Eucept was first approved by Korea’s Ministry of Food and Drug Safety in March for the treatment of rheumatoid arthritis, axial spondyloarthritis, and psoriasis.  Eucept is now the second Enbrel biosimilar to launch in Korea, following Samsung Bioepis’s Brenzys.

Prestige BioPharma and Alvogen announced the formation of an exclusive partnership to market Prestige BioPharma’s trastuzumab biosimilar, HervelousTM (HD201), in Central and Eastern Europe.  According to the announcement, Hervelous is a “biosimilar to Roche’s Herceptin® (trastuzumab), which is used to treat patients with HER2-overexpressing breast cancer [and] HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.”  The announcement states that HervelousTM is currently undergoing Phase 3 clinical trials with an aim to file with the EMA in 2019.