Samsung Biologics, a leading contract development and manufacturing organization (CDMO), has announced it’s acquiring full ownership of Samsung Bioepis, a biosimilars venture it had owned in partnership with biopharmaceutical company Biogen since 2012. Samsung Biologics will purchase Biogen’s 50% stake for $2.3 billion. With the acquisition of full ownership in Samsung Bioepis, the contract development and manufacturing company (CDMO) plans to accelerate its growth in biosimilars and novel therapeutics research and development.
The acquisition comes as Samsung Bioepis celebrates its 10th anniversary. In its decade of operation, the company has developed a total of 10 biosimilar products, including six currently available worldwide.
10 Years of Innovation in Biologic Medicine
Samsung Bioepis was founded as a joint venture between Samsung Biologics and Biogen. The company was created with the goal of increasing patient access to innovative biologic medicines of the highest quality, focusing on the development of biosimilars.
A biosimilar is a biologic medicine that has been shown to be highly similar to an approved reference medicine. Biosimilars must meet the same quality, safety, and efficacy standards that apply to all biological medicines. While biosimilars may feature minor differences from reference medicines in terms of clinically inactive components, there are no clinically meaningful differences in safety, purity, and potency. However, biosimilars can offer a cost-effective alternative for patients, as they are lower priced than branded products.
As a leading CDMO with robust capabilities in biologics, Samsung Biologics recognized the potential for biosimilar drug development to improve accessibility to high-quality biologic medicines, and it partnered with Biogen to pursue this growing area of the biopharma industry with the Samsung Bioepis joint venture.
According to research by the Organization for Economic Cooperation and Development, biologics will account for 31% of global pharmaceutical sales by 2024, and biosimilars stand to play a key role in keeping biologic medicines cost effective as they continue to increase in use. A recent RAND Corporation study estimated biosimilars would result in savings of $38.4 billion in spending on biologics in the U.S. alone from 2021 to 2025.
Samsung Bioepis has been a leader in this continued push for accessible, cost-effective biosimilars of the highest quality. Its first wave of biosimilars focused on therapies in immunology and oncology. The company’s infliximab, etanercept, and adalimumab biosimilars are the three most prescribed tumor necrosis factor inhibitors for immunological diseases, such as rheumatoid arthritis, across Europe. In oncology, Samsung Bioepis was the first company to launch a trastuzumab biosimilar in Europe, and its bevacizumab biosimilar received European Commission approval in August 2020. These medicines provide affordable access to innovative cancer treatments.
In a recent interview with The Financial Times, Samsung Biologics CEO John Rim said biosimilars are achieving faster market penetration in Europe than in the U.S., but he noted this is expected to change.
“The U.S. will start to pick up as well because all the health systems globally are under more pressure to reduce expenses and make [treatments] more available to patients,” said Rim.
“We have made remarkable achievements with a proven track record in just a decade, which is unprecedented in the biopharmaceutical industry,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis. “We are continuing to make history by pioneering in ophthalmology biosimilars, innovating the global health care landscape for caregivers, physicians, and patients alike. Seeing what we have built together over the last decade makes me optimistic about the future of our company and of the biosimilar industry.”
Next Steps for Samsung Biologics and Samsung Bioepis
Samsung Biologics is one of the largest CDMOs in the biopharma industry and it’s continuing to expand. Its acquisition of a full stake in Samsung Bioepis is expected to accelerate Samsung Bioepis’ biosimilar development capabilities and its move to novel drug development.
The acquisition comes as Samsung Biologics is expanding both its facilities and product portfolio. The CDMO is currently constructing its Plant 4 in South Korea, which will provide the world’s largest biomanufacturing CDMO capacity, and it’s pursuing the potential development of new facilities in the U.S. and Europe.
Samsung Biologics has played a leading role in mRNA vaccine production during the COVID-19 pandemic as a partner CDMO for Moderna and GreenLight Biosciences, and it’s adding mRNA drug development capabilities for end-to-end vaccine development and manufacturing. Already a leader in the development and manufacture of monoclonal antibodies, the recent moves in the mRNA and biosimilars spaces are building a foundation for Samsung Biologics to develop its drugs in these innovative areas.
“Our next decade will be marked by increased business expansion and portfolio diversification. While continuing to achieve best-in-class CDMO services and championing the biosimilar business, we will also lay the groundwork for novel drug development, to ultimately become a full-service biopharmaceutical company,” explained Samsung Biologics CEO John Rim at the 2021 J.P. Morgan Health Care Conference held in January.
Samsung Biologics plans to continue to grow and deliver its industry-leading CDMO services. It will maintain existing firewalls between Samsung Bioepis and Biologics, but the acquisition is indicative of the CDMO’s commitment to expanding its business in new and innovative areas.
