Samsung Biologics, a leading contract development and manufacturing organization (CDMO), is in the process of what CEO John Rim calls “multidimensional growth.” After recording record revenues and 35% revenue growth in 2021, the company recently announced 96% year-over-year revenue growth for the first quarter of 2022. As part of Samsung Biologics’ plans to continue growing, the company is investing profits into diversifying its portfolio in two innovative areas of biologic medicine: mRNA vaccine production and biosimilars.
What Is mRNA Vaccine Production?
Traditional vaccines are designed to trigger the production of antibodies. This involves injecting a small amount of the target virus. mRNA vaccines depart from this approach. Rather than inject a virus directly to stimulate a response, these vaccines are designed to introduce genetic material, mRNA, into the body. This mRNA then instructs the body’s cells to construct the proteins needed to carry out an immune response specific to a particular illness, from COVID-19 to cancer.
mRNA vaccine production differs from traditional vaccine production. Most viral vaccines involve growing a form of a virus in chicken eggs or mammalian cells. This process can take months, as the virus must be collected, adapted to a lab, and shipped to different locations. On the other hand, mRNA vaccine production is a cell-free process that involves synthesizing DNA based on an electronic sequence that can be shared via computer, enabling experimental batches to be easily edited and shared much faster, with a batch typically produced in about a week.
“The capability for mRNA to be easily edited not only makes it the ideal tool to combat viruses that can quickly mutate, but also gives it the potential to be used in the treatment of countless other diseases,” said James Choi, Executive Vice President and Chief Information and Marketing Officer at Samsung Biologics, in a recent interview with the European Pharmaceutical Review.
Samsung Biologics’ Expanded mRNA Capabilities
While research into the benefits of mRNA vaccines has been ongoing for decades, it wasn’t until COVID-19 hit that the first mRNA vaccines were approved for human use. Because mRNA vaccines can be quickly tested, edited, and produced, they were ideal for addressing a global pandemic.
Samsung Biologics played an important role in mRNA vaccine production for COVID-19 vaccines, providing fill/finish services for Moderna’s vaccine at its facilities in Songdo, South Korea.
“Samsung Biologics was the first in Korea to perform fill/finish manufacturing of Moderna’s COVID-19 mRNA vaccine and obtain approval from the Korean Ministry of Food and Drug Safety (MFDS),” said Samsung Biologics CEO John Rim in a letter to shareholders. “Samsung Biologics will continue to dedicate itself to providing a reliable supply of COVID-19 vaccines and treatments and contribute to the ending of the prolonged COVID-19 global pandemic.”
But Samsung Biologics is not limiting itself to fill/finish services or COVID-19 mRNA vaccine production. The CDMO has built an mRNA drug substance manufacturing facility, enabling it to produce the active drug substance in mRNA vaccines in addition to providing the aseptic fill/finish services that result in the finished drug product. With the ability to produce mRNA drug substances at its facility in Songdo rather than receive shipments of mRNA, Samsung Biologics can now provide end-to-end mRNA vaccine production and deliver vaccines on a faster timescale.
What Are Biosimilars?
In addition to mRNA vaccine production, Samsung Biologics is accelerating biosimilar growth. .
Biosimilars are biologic medicines demonstrated to be highly similar to an approved reference medicine. This means they must meet the same safety, quality, and efficacy standards that apply to the reference biologic, but may feature minor differences in terms of clinically inactive components. Biosimilars offer a cost-effective alternative for patients, as they are often lower priced than the reference medicine, similar to the relationship between generic and nongeneric drugs.
Samsung Bioepis Acquisition and the Future of Biosimilars
Samsung Biologics’ expansion into biosimilars is built around its full acquisition of Samsung Bioepis, a biosimilars company started as a joint venture by Samsung Biologics and Biogen in 2012. In April 2022, Samsung Biologics announced the completion of its full acquisition of Biogen’s shares in Bioepis with an initial payment of $1 billion in paid-in capital and plans to pay an additional $1.3 billion over two years.
Samsung Bioepis has developed 10 biosimilars, including six currently available worldwide. In its initial 10 years of operation, the company has focused on immunology and oncology applications for biosimilars, but it’s currently pursuing new areas of unmet need in endocrinology, gastroenterology, hematology, and ophthalmology.
“By acquiring the full ownership of Samsung Bioepis, as announced in January this year, Samsung Biologics will leap forward as a global biopharmaceutical company with three business areas: CDMO, biosimilar, and new drugs,” said Rim.
Portfolio Diversity a Pillar of Growth
With its expansion in mRNA vaccine production and biosimilars capabilities, Samsung Biologics is focusing on the diversity of its portfolio, which Rim calls a “core pillar” in the company’s growth strategy. While Samsung Biologics provides industry-leading CDMO capacity, the diversification of its portfolio is a step toward extending beyond traditional CDMO services and becoming a global leader in the biopharmaceutical industry more generally.
“As part of our vision, we are now venturing into the three core pillars of our multidimensional growth plan, encompassing expanded manufacturing capacity, continued advancements in business portfolio, and greater global footprint,” said Rim. “As a leading CDMO service provider, we will continue to demonstrate our excellent business operations throughout our value chains to ultimately contribute to saving the lives of patients and build a better future for all.”
