Biosimilar Market Updates

During the first weeks of 2019 a number of biosimilar developers announced updates regarding their plans for the future.

Bio-Thera Solutions Partners with Cipla for Bevacizumab Biosimilar Candidate

On January 14, 2019, Bio-Thera Solutions Ltd announced that it has entered into a licensing agreement with Cipla Limited for BAT-1706, its bevacizumab biosimilar candidate.  According to the press release, under the agreement, Cipla will have exclusive rights to distribute and market the drug in selected markets.

BAT-1706, which is currently in a global Phase III study, is a proposed biosimilar to Genentech’s Avastin®.  Avastin® is currently approved for several indications, including metastatic colorectal cancer, recurrent glioblastoma, and non-squamous non-small cell lung cancer.  According to the press release, Bio-Thera will be responsible for full development, product registration with the FDA and EMA, and commercial supply of BAT1706.

Celltrion to Establish Direct Sales Network

According to an article in the Korea Herald, Celltrion announced at a recent press conference that it will establish a direct sales network worldwide in an effort to secure price competitiveness and lead the global biosimilar market.

Celltrion’s founder and Chairman Seo Jung-jin was quoted as saying, “[w]ith Remsima SC, we will be directly selling it worldwide.”  Remsima SC is a subcutaneous infliximab biosimilar of Johnson & Johnson’s autoimmune disease treatment Remicade®.

The article further quoted Seo: “Setting up the direct sales system will not just end there but act as an expressway for local pharmaceutical companies in advancing overseas.”

Samsung Bioepis Expanding Biosimilar Business into Mainland China

On January 6, 2019, Samsung Bioepis Co., Ltd. announced that it had entered into a licensing agreement with 3SBio Inc. that will allow Samsung Bioepis to expand its biosimilar business into mainland China.  The agreement covers multiple biosimilar products, including SB8, a bevacizumab biosimilar candidate referencing AVASTIN®.  According to the press release, Samsung Bioepis and 3SBio will work together across a number of areas, including clinical development, regulatory registration and commercialization in China.