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Samsung Bioepis and Organon’s Reports US FDA’s Acceptance of sBLA for Review of SB5 (biosimilar, adalimumab) for Rheumatoid Arthritis

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Samsung Bioepis and Organon’s Reports US FDA’s Acceptance of sBLA for Review of SB5 (biosimilar, adalimumab) for Rheumatoid Arthritis

Samsung Bioepis and Organon’s Reports US FDA’s Acceptance of sBLA for Review of SB5 (biosimilar, adalimumab) for Rheumatoid Arthritis

Shots:

  • The US FDA has accepted the sBLA for a citrate-free, high-concentration (100 mg/mL) formulation of SB5, a biosimilar referencing Humira (adalimumab). SB5 will be commercialized in the US by Organon & is expected to launch in the US on July 1, 2023
  • The sBLA was based on the clinical data from a single-dose study to evaluate the PK, safety, tolerability, and immunogenicity of SB5 (100 mg/mL vs 50 mg/mL) in healthy volunteers
  • In July 2019, SB5 has approved in the US under the brand name Hadlima as a low-concentration (50 mg/mL) formulation. Additionally, the low & high concentration forms of the reference product are marketed in the US

Ref: Center for Biosimilars | Image: The Korea Herald

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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