Samsung Biologics announced Tuesday it has signed its largest contract ever—a $1.06 billion manufacturing deal with an unnamed pharmaceutical company headquartered in the U.S.
Samsung Biologics has entered into a $1.06 billion agreement with an unnamed U.S. pharmaceutical company, according to a public disclosure the Korean manufacturer made on Tuesday.
Details of the partnership were sparse as Samsung Bio only revealed that its partner was headquartered in the U.S. but did not name the company due to a non-disclosure agreement, according to Korea JoongAng Daily. The contract manufacturer has also not provided information about its obligations and responsibilities under the agreement.
The timeline of the contract is also largely unknown, with Korea JoongAng Daily only reporting that Samsung Bio and the unnamed pharma signed the original letter of intent in June 2023, but that the deal’s scope has since expanded requiring the contract manufacturer to file a revised disclosure. The agreement runs through 2030.
The deal is Samsung Bio’s largest contract ever since its establishment in 2011, according to Korea JoongAng Daily. It also marks the contract manufacturers’ seventh agreement this year, which together amount to $1.8 billion. In 2023, Samsung Bio’s total revenue was around $2.7 billion.
With four operational plants, Samsung Bio has a total manufacturing capacity of 604 kilo-liters. A fifth plant, slated to open in April 2025, will bump its capacity up by another 180,000 liters. By 2032, Samsung Bio also expects to fully complete its second BioCampus, which will house a fifth manufacturing facility along with two others and is set to add 720 kilo-liters of manufacturing volume to its capacity.
In addition to producing biologic products, the Korean company also conducts cell line and process development, clinical manufacturing and bioconjugation for antibody-drug conjugates. Samsung Bio also performs quality, biosafety and analytical testing.
Tuesday’s agreement with Samsung Bio could be part of the U.S. biopharma industry’s efforts to look for alternative manufacturers as the BIOSECURE Act potentially threatens business with certain Chinese service providers.
Introduced by Reps. Mike Gallaghher (R-Wis.) and Raja Krishnamoorthi (D-Ill.) in January 2024, the BIOSECURE Act is designed to prevent “foreign adversary biotech companies” from accessing taxpayer dollars. Five companies are currently explicitly named by the bill: WuXi AppTec, Beijing Genomics Institute, Complete Genomics, WuXi Biologics, and MGI.
In May 2024, Krishnamoorthi and Rep. Brad Wenstrup (R-Ohio) introduced an amended bill which includes a grandfather clause that would give leeway to existing contracts with China-based firms until January 1, 2032.
The BIOSECURE Act is expected to have far-reaching implications across the industry, as many companies rely on Chinese manufacturers for their commercial and pipeline products. The fallout from the proposed legislation could affect small players but could also compromise the operations of bigger and more established companies such as Merck, Iovance and Kyverna.
