# Samsung Biologics (삼성바이오로직스)
**Samsung Biologics** (삼성바이오로직스; KRX: 207940.KS) is a South Korean contract development and manufacturing organization (CDMO) that develops and produces biologic medicines for pharmaceutical and biotechnology clients, operating large-scale mammalian cell culture plants in Songdo, Incheon and, since 2026, in [Rockville, Maryland](https://www.edgepedia.org/rockville-maryland).[1](https://samsungbiologics.com/front/en/aboutUs/factSheet.do) The company was established in April 2011 as part of the Samsung Group's entry into biopharmaceuticals and is listed on the [Korea Exchange](https://www.edgepedia.org/korea-exchange).[2](https://englishdart.fss.or.kr/dsbc001/selectPopup.ax?selectKey=00877059)
| Key fact | Detail |
|---|---|
| Founded | April 2011 (corporate registration 22 April 2011), headquartered in Songdo, Incheon, South Korea[2](https://englishdart.fss.or.kr/dsbc001/selectPopup.ax?selectKey=00877059) • [3](https://images.samsung.com/is/content/samsung/p5/sa_en/aboutsamsung/2014_English.pdf) |
| Listing | IPO on KOSPI in November 2016; at the time the second-largest IPO in the global biotech sector[4](https://samsungbiologics.com/media/company-news/samsung-biologics%E2%80%99-statement-regarding-recent-media-reports-regarding-the-samsung-biologics-ipo) |
| Total capacity | 845,000 L of drug substance capacity across five Songdo plants and the Rockville, Maryland site[1](https://samsungbiologics.com/front/en/aboutUs/factSheet.do) |
| Clients | 145+ global clients, including 17 of the world's top 20 pharmaceutical companies[5](https://news.samsung.com/us/samsung-biologics-expands-united-states-acquisition-rockville-biologics-manufacturing-facility/) |
| FY2025 results | Revenue KRW 4,557 billion (+30.3% year on year); operating profit KRW 2,069.2 billion (+56.6%)[6](https://samsungbiologics.com/media/company-news/samsung-biologics-reports-fourth-quarter-and-fiscal-year-2025-financial-results) |
| Corporate structure | Pure-play CDMO since November 2025, after spinning off Samsung Bioepis into Samsung Epis Holdings[7](https://samsungbiologics.com/media/company-news/samsung-biologics-completes-spin-off-to-strengthen-its-focus-as-a-pure-play-cdmo) |
| Recognition | CDMO Leadership Awards for 13 consecutive years, selected by clients[1](https://samsungbiologics.com/front/en/aboutUs/factSheet.do) |
## History
Samsung announced biopharmaceuticals as one of five new strategic growth businesses in May 2010, committing to invest 2.1 trillion won (about $2 billion) in the sector by 2020.[8](https://investors.biogen.com/node/17456/pdf) Samsung Biologics was founded in April 2011, headquartered in Songdo in Korea's Incheon Free Economic Zone, with a stated focus on "Quality First" development and manufacturing of bio-healthcare products.[3](https://images.samsung.com/is/content/samsung/p5/sa_en/aboutsamsung/2014_English.pdf) [Samsung Electronics](https://www.edgepedia.org/samsung-electronics) participated in the company's capital with a KRW 90 billion investment authorized in July 2011.[9](https://www.samsung.com/global/ir/reports-disclosures/public-disclosure-view.70476/)
**Plant build-out and listing.** Plant 1 (30,000 L) reached cGMP readiness in 2013, Plant 2 (155,000 L) in 2016, and Plant 3 (180,000 L) in 2017; the company received its first FDA approval of Plant 1 in November 2015 and held its IPO on KOSPI in November 2016.[10](https://samsungbiologics.com/about/milestones) Plant 4 (240,000 L) was completed in October 2022.[10](https://samsungbiologics.com/about/milestones)
**Samsung Bioepis.** In 2012, Samsung Biologics and Biogen Idec formed the biosimilars joint venture Samsung Bioepis Co., Ltd., with a research and development center at the Songdo site.[8](https://investors.biogen.com/node/17456/pdf) Samsung Biologics completed the full acquisition of Samsung Bioepis in April 2022 with a first payment of USD 1.0 billion, making it a wholly owned subsidiary.[11](https://samsungbiologics.com/media/company-news-view?boardseq=1681) In November 2025 the company completed a spin-off of Samsung Bioepis, separating its investment and subsidiary management business into a new holding company, Samsung Epis Holdings, which also oversees a new subsidiary focused on next-generation biotechnology platforms. The spin-off was approved by shareholders with 99.9% support and completed within five months of its announcement; Samsung Biologics shares were re-listed on November 24, 2025.[7](https://samsungbiologics.com/media/company-news/samsung-biologics-completes-spin-off-to-strengthen-its-focus-as-a-pure-play-cdmo) • [12](https://www.samsungepisholdings.com/en/newsroom/newsroomView.do?idx=498) After the separation, Samsung Biologics operates as a pure-play CDMO.[7](https://samsungbiologics.com/media/company-news/samsung-biologics-completes-spin-off-to-strengthen-its-focus-as-a-pure-play-cdmo)
## Manufacturing network
The company's Songdo campuses hold the bulk of its capacity. Bio Campus I houses Plants 1 through 4 with a combined 605,000 L, and Bio Campus II adds Plant 5, a 180,000 L facility (twelve 15,000 L trains) that became cGMP ready in April 2025.[1](https://samsungbiologics.com/front/en/aboutUs/factSheet.do) • [10](https://samsungbiologics.com/about/milestones) Bio Campus II is planned for completion by 2032 with three further 180,000 L plants (Plants 6, 7, and 8) and an Open Innovation Center, bringing the campus total to 720 kL; the company has stated a goal of 1,324,000 L of total capacity by 2032.[13](https://samsungbiologics.com/about/bio-campus2) • [7](https://samsungbiologics.com/media/company-news/samsung-biologics-completes-spin-off-to-strengthen-its-focus-as-a-pure-play-cdmo)
**First U.S. site.** On March 31, 2026, Samsung Biologics completed the $353 million acquisition of GSK's manufacturing facility in Rockville, Maryland, its first manufacturing presence in the United States. The site comprises two cGMP plants with a combined 60,000 L of drug substance capacity for clinical and commercial production, raising total global capacity to 845,000 L.[14](https://samsungbiologics.com/media/company-news/samsung-biologics-completes-acquisition-of-gsks-manufacturing-facility-in-rockville-maryland) The company is evaluating an expansion of up to 40,000 L at the site.[15](https://samsungbiologics.com/about/worldwide) A dedicated antibody-drug conjugate (ADC) facility in Songdo, equipped with reactors of up to 500 L, began operations in early 2025.[16](https://samsungbiologics.com/ir/resource/notice-view?boardseq=3230) • [17](https://www.cmbi.com.hk/upload/202509/20250901793716.pdf)
By BioPlan's ranking, the Incheon BioCampus is the world's largest single biopharmaceutical facility by production capacity, first in the Top 1000 Global Biopharmaceutical Facilities Index.[18](https://top1000bio.com/) • [19](https://www.ajupress.com/view/20260407183370211)
## Services and clients
Samsung Biologics provides end-to-end services spanning cell line development, process and analytical development, drug substance manufacturing, drug product manufacturing, and aseptic fill-finish, with batch sizes for fill-finish ranging from 5 L to 2,500 L and capacity of up to 350,000 vials per day.[20](https://samsungbiologics.com/services/biologics-overview) • [21](https://samsungbiologics.com/services/cmo/drug-product) Its development platform targets gene-to-IND timelines of 9 months for monoclonal antibodies and under 11 months for bispecific antibodies.[22](https://samsungbiologics.com/front/en/ourServices/cdo/overview.do) Modalities covered include monoclonal antibodies, bispecific antibodies, ADCs, mRNA, and recombinant proteins.[20](https://samsungbiologics.com/services/biologics-overview)
The company serves more than 145 global clients, including 17 of the top 20 pharmaceutical companies such as [AstraZeneca](https://www.edgepedia.org/astrazeneca), Eli Lilly, and Pfizer.[5](https://news.samsung.com/us/samsung-biologics-expands-united-states-acquisition-rockville-biologics-manufacturing-facility/) In January 2025 it signed a CMO agreement worth approximately USD 1.4 billion (KRW 2 trillion) with a leading European pharmaceutical company, the largest single order in its history.[16](https://samsungbiologics.com/ir/resource/notice-view?boardseq=3230) Cumulative contract value reached USD 21.6 billion by the second quarter of 2026.[23](https://samsungbiologics.com/media/company-news/samsung-biologics-reports-second-quarter-2026-financial-results) Annual CMO contract value grew from $3.1 billion in 2016 to $16.3 billion in 2024, according to a Bourne Partners industry report.[24](https://bourne-partners.com/wp-content/uploads/2025/09/CDMO-Report-March-2025_Bourne-Partners.pdf)
## Financial performance
Revenue has grown steadily: KRW 1,165 billion in 2020, KRW 2,437 billion in 2021, KRW 2,938 billion in 2022, KRW 3,497 billion in 2024, and KRW 4,557 billion in 2025.[25](https://samsungbiologics.com/ir/financial-info/financial-snapshot) [Fiscal year](https://www.edgepedia.org/fiscal-year) 2025 operating profit was KRW 2,069.2 billion, up 56.6%, with an EBITDA of KRW 2,439.1 billion; the company guided to 15 to 20 percent revenue growth for 2026, excluding contributions from the U.S. site acquisition.[6](https://samsungbiologics.com/media/company-news/samsung-biologics-reports-fourth-quarter-and-fiscal-year-2025-financial-results) In the second quarter of 2026 it reported revenue of KRW 1,321 billion and operating profit of KRW 586 billion, with Plants 1 through 4 in full operation.[23](https://samsungbiologics.com/media/company-news/samsung-biologics-reports-second-quarter-2026-financial-results) Jefferies analysis placed the company fourth in global CDMO sales in 2024 at $3.27 billion, behind Lonza, Thermo Fisher, and Catalent.[19](https://www.ajupress.com/view/20260407183370211)
## Regulatory record and FDA inspections
The company reports a cumulative total of 464 global regulatory approvals through 2026 across the FDA, EMA, and other agencies such as PMDA and MFDS, up from 284 at the end of 2023.[1](https://samsungbiologics.com/front/en/aboutUs/factSheet.do) Its own quarterly reporting cited 420 cumulative approvals as of the fourth quarter of 2025.[6](https://samsungbiologics.com/media/company-news/samsung-biologics-reports-fourth-quarter-and-fiscal-year-2025-financial-results)
FDA inspections have also produced critical findings. A Form 483 issued after an inspection of the Yeonsu, Incheon drug substance plant from May 19 to 27, 2025 cited data integrity deficiencies, including a deviation in which the Quality Systems Director attempted to identify an employee who had anonymously reported falsification of testing data, and a case in which a shift supervisor instructed operators to change documented lot and serial numbers without verification.[26](https://www.fda.gov/media/189387/download) In a complete response letter for a biologics license application for [cosibelimab](https://www.edgepedia.org/cosibelimab), FDA stated that, following evaluation of inspection findings at the Incheon facility, it had identified concerns regarding the reliability of data generated at Samsung Biologics in the submission.[27](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761297Orig1s000OtherActionLtrs.pdf) ProPublica's Rx Inspector database entry for the facility lists a warning letter dated July 30, 2024.[28](https://projects.propublica.org/rx-inspector/facilities/3010479596/) A Form 483 records inspectional observations and does not constitute a final agency determination of a violation.[29](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions)
## References
1. [Samsung Biologics Fact Sheet](https://samsungbiologics.com/front/en/aboutUs/factSheet.do)
2. [Samsung Biologics company information, DART (Financial Supervisory Service of Korea)](https://englishdart.fss.or.kr/dsbc001/selectPopup.ax?selectKey=00877059)
3. [Samsung 2014 annual publication, Samsung BioLogics section](https://images.samsung.com/is/content/samsung/p5/sa_en/aboutsamsung/2014_English.pdf)
4. [Samsung Biologics' statement regarding recent media reports regarding the Samsung Biologics IPO](https://samsungbiologics.com/media/company-news/samsung-biologics%E2%80%99-statement-regarding-recent-media-reports-regarding-the-samsung-biologics-ipo)
5. [Samsung Biologics expands into the United States: Acquisition of Rockville biologics manufacturing facility, Samsung Newsroom US](https://news.samsung.com/us/samsung-biologics-expands-united-states-acquisition-rockville-biologics-manufacturing-facility/)
6. [Samsung Biologics reports fourth quarter and fiscal year 2025 financial results](https://samsungbiologics.com/media/company-news/samsung-biologics-reports-fourth-quarter-and-fiscal-year-2025-financial-results)
7. [Samsung Biologics completes spin-off to strengthen its focus as a pure-play CDMO](https://samsungbiologics.com/media/company-news/samsung-biologics-completes-spin-off-to-strengthen-its-focus-as-a-pure-play-cdmo)
8. [Samsung Biologics and Biogen Idec Announce Formation of Biosimilars Joint Venture Samsung Bioepis, Biogen investor relations](https://investors.biogen.com/node/17456/pdf)
9. [Samsung public disclosure: capital investment in Samsung Biologics rights offering, July 2011](https://www.samsung.com/global/ir/reports-disclosures/public-disclosure-view.70476/)
10. [Samsung Biologics Milestones](https://samsungbiologics.com/about/milestones)
11. [Samsung Biologics completes full acquisition of Samsung Bioepis](https://samsungbiologics.com/media/company-news-view?boardseq=1681)
12. [Newly Established Samsung Epis Holdings to Drive Growth for Samsung Bioepis and a New Subsidiary](https://www.samsungepisholdings.com/en/newsroom/newsroomView.do?idx=498)
13. [Bio Campus II, Samsung Biologics](https://samsungbiologics.com/about/bio-campus2)
14. [Samsung Biologics completes acquisition of GSK's manufacturing facility in Rockville, Maryland](https://samsungbiologics.com/media/company-news/samsung-biologics-completes-acquisition-of-gsks-manufacturing-facility-in-rockville-maryland)
15. [Samsung Biologics Worldwide locations](https://samsungbiologics.com/about/worldwide)
16. [2025 1Q CEO IR Newsletter, Samsung Biologics](https://samsungbiologics.com/ir/resource/notice-view?boardseq=3230)
17. [CMBIS research report on ADC capabilities](https://www.cmbi.com.hk/upload/202509/20250901793716.pdf)
18. [BioPlan's Top 1000 Global Biopharmaceutical Facilities Index](https://top1000bio.com/)
19. [Korean Biotech CDMOs Expand From Manufacturing to Integrated Services, Aju Press](https://www.ajupress.com/view/20260407183370211)
20. [Our Services, Samsung Biologics](https://samsungbiologics.com/services/biologics-overview)
21. [Drug Product Manufacturing, Samsung Biologics](https://samsungbiologics.com/services/cmo/drug-product)
22. [Biopharma Development Services, Samsung Biologics](https://samsungbiologics.com/front/en/ourServices/cdo/overview.do)
23. [Samsung Biologics Reports Second Quarter 2026 Financial Results](https://samsungbiologics.com/media/company-news/samsung-biologics-reports-second-quarter-2026-financial-results)
24. [CDMO Report March 2025, Bourne Partners](https://bourne-partners.com/wp-content/uploads/2025/09/CDMO-Report-March-2025_Bourne-Partners.pdf)
25. [Financial Snapshot, Samsung Biologics](https://samsungbiologics.com/ir/financial-info/financial-snapshot)
26. [FDA Form 483, Samsung Biologics Co, Yeonsu, Korea, May 2025](https://www.fda.gov/media/189387/download)
27. [Complete response letter, cosibelimab BLA 761297, FDA](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761297Orig1s000OtherActionLtrs.pdf)
28. [FDA Inspection Reports for Samsung Biologics Co., Ltd., ProPublica Rx Inspector](https://projects.propublica.org/rx-inspector/facilities/3010479596/)
29. [FDA Form 483 Frequently Asked Questions](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions)
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*Topic: Encyclopedia › Technology and the built world › Engineering and manufacturing › Manufacturing industries and companies › Chemical, materials, and metals companies*
*Initially written Sep 17, 2026 · Reviewed: Sep 18, 2026; Oct 15, 2026 · Edited: Sep 18, 2026; Oct 15, 2026 · Last review: Oct 15, 2026*
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License: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license