SOUTH KOREA — In an exciting development for the biologics manufacturing sector, Samsung Biologics, based in South Korea, has announced a significant expansion of its 2022 agreement with Novartis.

The original partnership, valued at US$81 million, has now transformed into a five-year deal worth nearly US$391 million, showcasing a remarkable US$309 million expansion. This groundbreaking collaboration will greatly aid Novartis in its biologics manufacturing endeavors.

Confirming this strategic move, a spokesperson from Novartis revealed that the company had signed a letter of intent with Samsung Biologics to secure the necessary capacity for the production of biologics drug substances.

The agreement solidifies Samsung Biologics’ facility in Korea as an additional supply point for Europe and other markets experiencing a surge in demand for Novartis biologics.

The comprehensive manufacturing and supply agreement, scheduled to span from 2024 to 2028, will primarily focus on drug substance production.

Leveraging the state-of-the-art facilities of Samsung, headquartered in Korea, the partnership aims to address the growing needs for Novartis biologics in Europe and other expanding markets.

Samsung’s commitment to advancing biopharmaceutical manufacturing is evident through its groundbreaking Incheon-based facility.

Boasting a staggering 2.5 million square feet, the US$2 billion “superplant” commenced partial operations last year and is now recognized as the largest biopharmaceutical manufacturing facility worldwide.

With the completion of this site, Samsung will add an impressive 240,000 liters of capacity, further enhancing its overall manufacturing capability to a remarkable 604,000 liters.

Continuing on its path of transformative collaborations, Samsung Biologics recently forged a long-term strategic manufacturing partnership with Pfizer.

Under this agreement, Samsung will undertake the production of Pfizer’s proprietary commercial biologic medicines.

This momentous deal entails an “additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio,” encompassing critical therapeutic areas such as oncology, inflammation, and immunology.

Described as a “long-term” arrangement, this partnership highlights Samsung’s commitment to pushing the boundaries of biologic medicine manufacturing.

Notably, Pfizer’s biosimilar portfolio includes replicas of Roche’s cancer medications, including Rituxan, Avastin, and Herceptin, as well as biosimilar versions of Johnson & Johnson’s Remicade and Amgen’s Neupogen.

It is speculated that the Samsung collaboration may also encompass the production of Pfizer’s biosimilar to AbbVie’s Humira, a highly successful drug that generated sales of US$21.24 billion in the previous year.

While Amgen has already entered the market with a Humira biosimilar, Pfizer, alongside numerous other players, is poised to make a significant impact in the industry this year.

In a recent financial filing, Samsung Biologics estimated the value of the Pfizer partnership at US$411 million, making it the company’s most substantial agreement to date, surpassing the previous top deal of US$359.7 million with AstraZeneca.

This collaboration further solidifies Samsung’s position as a leader in the biopharmaceutical manufacturing space.

As part of its ambitious growth plans, Samsung Biologics also announced the forthcoming opening of Plant 5, a state-of-the-art facility valued at US$1.5 billion.

Anticipated to be operational by April 2025, Plant 5 will augment Samsung’s campus in Incheon, South Korea, with an additional 180,000 liters of capacity.

With a total capacity of 784,000 liters, this facility will hold the industry record for the most significant capacity at a single site.

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