Celltrion

Celltrion

Celltrion

South Korean biopharmaceutical company

Celltrion, Inc. (Korean: 주식회사 셀트리온) is a biopharmaceutical company headquartered in Incheon, South Korea. Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion.[2] Celltrion's founder, Seo Jung-jin, is the richest person in South Korea.[3]

Quick Facts Company type, Traded as ...

History

In 1999, Nexol, Inc. (now Celltrion Healthcare Co., Ltd.) was founded as a global business management consulting firm. In 2002, Celltrion, Inc. was founded as a biopharmaceutical company.[4]

In 2008, Nexol and Celltrion established a global distribution agreement.[5]

In 2009, distribution channels were established in America, Oceania, Europe (Hospira) and Nexol, Inc. renamed as Celltrion Healthcare Co., Ltd.

In 2010, distribution channels were established in Japan (Nippon Kayaku), Commonwealth of Independent States (CIS), Eastern Europe, and the Middle East (Egis).

In 2013, distribution channels were added in Europe (Mundipharma, Biogaran, and Kern).[6][7]

Products

The company's products are manufactured at mammalian cell culture facilities designed and built to comply with the United States FDA’s cGMP,[8] and the European Medicines Agency’s GMP standards.[9]

Inline product

Remsima (infliximab) is a biosimilar monoclonal antibody against tumor necrosis factor alpha (TNF-α), approved by the European Medicines Agency (EMA) for treatment of:

  1. rheumatoid arthritis,
  2. adult Crohn's disease,
  3. pediatric Crohn's disease,
  4. ulcerative colitis,
  5. pediatric ulcerative colitis,
  6. ankylosing spondylitis,
  7. psoriatic arthritis, and
  8. psoriasis.[10]

In 2012 Remsima was approved by the Republic of Korea's Ministry of Food and Drug Safety (MFDS), previously known as Korea Food and Drug Administration and in 2013 it became the world's first[11] biosimilar monoclonal antibody (mAb) approved by the EMA.[10]

Herzuma is a biosimilar trastuzumab approved by the MFDS for treatment of early and advanced (metastatic) HER2+ breast cancer as well as advanced (metastatic) stomach cancer. Herzuma is a HER2+ breast cancer therapy designed to treat aggressive HER positive metastatic and adjuvant breast cancer, as well as HER2 positive adenocarcinoma of the stomach that has spread (metastatic or advanced gastric cancer).[12][13][14]

Truxima (previously known as CT-P10) is the first biosimilar of the reference monoclonal antibody rituximab that targets CD20 molecule primarily found on the surface of B-cells. Its target indications are rheumatoid arthritis, non-Hodgkin lymphoma and chronic lymphocytic leukemia.[15][16] It was approved by the EMA in February 2017.[17]

See also

References

  1. [1]
    "Financial Information Celltrion Co., Ltd". Celltrion.
  2. [2]
    "Company Overview of Celltrion Healthcare Co., Ltd". Bloomberg.
  3. [3]
    Kang, John. "Korea's New No. 1: Celltrion Cofounder Becomes First Self-Made Billionaire To Claim Top Spot". Forbes. Retrieved 2021-08-06.
  4. [4]
    "History | ABOUT US". www.celltrionhealthcare.com. Retrieved 2020-01-22.
  5. [5]
    "VaxGen Biopharmaceutical Manufacturing Plant - Pharmaceutical Technology". Retrieved 2020-01-22.
  6. [6]
    MacDonald, Gareth (15 October 2014). "Biosimilars going global but EMA still setting the regulatory pace". BioPharma-reporter.com.
  7. [7]
    Indukern Group Press Release 2015. Indukern Group Press Release
  8. [8]
    "S.Korea's Celltrion gets FDA OK to make Bristol-Myers' Orencia". Reuters. 18 December 2007. Archived from the original on 24 September 2015. Retrieved 30 June 2017.
  9. [9]
    "Europe approves first biosimilar antibody drug". Reuters. 10 September 2013. Archived from the original on 24 September 2015. Retrieved 30 June 2017.
  10. [10]
    "Remsima Assessment report" (PDF). Committee for Medicinal Products for Human Use (CHMP). June 27, 2013.
  11. [11]
    Stanton, Dan (17 July 2013). "EMA Approves First MAb Biosimilars". BioPharma-reporter.com.
  12. [12]
    "Biosimilar trastuzumab approved in Korea". Generics and Biosimilars Initiative. 17 January 2014.
  13. [13]
    "Herzuma approved by the Ministry of Food and Drug Safety of the Republic of Korea". Ministry of Food and Drug Safety of the Republic of Korea. 15 January 2014.
  14. [14]
    "Celltrion gets nod for 2nd biosimilar in local market". JoongAng Ilbo. 16 January 2014.
  15. [15]
    "A Randomized, Controlled, Multicenter, 2‑Arm, Parallel‑Group, Double-Blind Study To Demonstrate The Equivalence Of CT-P10 To Innovator Rituximab With Respect To Pharmacokinetic Profile In Patients With Rheumatoid Arthritis", ACR/ARHP Annual Meeting 2013, ACR/ARHP Annual Meeting, 2013, archived from the original on 2015-04-15, retrieved 2013-10-28
  16. [16]
    Brinks, Vera (December 15, 2005), Immunogenicity of biosimilar monoclonal antibodies, Generics and Biosimilars Initiative, retrieved September 20, 2013
  17. [17]
    "Celltrion's Rituximab Biosimilar Truxima Approved in Europe - GEN". GEN. 22 February 2017.
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