GSK and Samsung Biologics Enter $231 Million Partnership to Expand Biologics Manufacturing Capacity

On May 21, GSK and Samsung Biologics entered into an agreement to establish a partnership, under which the latter will help GSK expand its production capacity for innovative biologics.

Under the terms of the agreement, Samsung Biologics will flexibly provide additional large-scale biologics manufacturing capacity to meet GSK’s future needs, serving as a supplement to GSK’s existing production network. Over the next eight years, GSK will pay Samsung Biologics no less than $231 million. The collaboration will commence with the commercial manufacturing of the lupus drug Benlysta (belimumab), with GSK initiating technology transfer to Samsung Biologics in 2020 and first commercial supplies expected in 2022. The scope of future cooperation will also expand to include other specialty medicines.

GSK’s current commercial portfolio is primarily focused on small-molecule drugs in the areas of respiratory diseases, infectious diseases, and neuroscience/psychiatry. Apart from vaccines, there are very few therapeutic biologics. Benlysta, first approved in 2011, was the first new-mechanism drug for lupus erythematosus in 60 years. Its global sales reached $785 million in 2019 (+24.8%), and it was also approved in China in July 2019. Another notable product is Nucala (mepolizumab), an IL-5 monoclonal antibody for asthma treatment, which achieved global sales of $983 million in 2019 (+31.2%).

Compared with other pharmaceutical giants such as Merck & Co. and AbbVie, GSK had not been overly reliant on biologics in the past. However, global demand for biologics is growing steadily. GSK’s two current monoclonal antibody products are experiencing rapid growth, and its strategic shift back into oncology—bolstered by the acquisition of Tesaro to enhance its oncology biologic pipeline—has further intensified this trend. With its BCMA-targeting antibody-drug conjugate (ADC) and the PD-1 inhibitor dostarlimab both nearing market launch, GSK faces bottlenecks in its biologics manufacturing capacity. It is therefore logical for GSK to partner with Samsung Biologics, the South Korean CDMO giant. Samsung Biologics has invested $2.6 billion to expand its production capacity, bringing the total capacity across its three plants to 362,000 liters. In 2019, Samsung Biologics reported revenue of $565 million.

Regis Simard, President of GSK’s Pharmaceutical Supply Chain, stated: “The agreement with Samsung Biologics complements and strengthens our existing world-class pharmaceutical manufacturing capabilities, helping to ensure that we can continue to reliably provide patients with the innovative biologics they need.”

Dr. Tae Han Kim, CEO of Samsung Biologics, stated, “We are delighted to enter into this long-term agreement with GSK. Samsung Biologics’ goal in entering the biopharmaceutical industry is to help our customers bring valuable biologics to patients more quickly, and we are pleased to partner with GSK, which shares the same vision.”