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HADLIMA® (adalimumab injection) Now Available for the Treatment of Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing ...

HADLIMA ® is a biosimilar biologic drug (biosimilar) to the reference biologic drug HUMIRA ®. A biosimilar is authorized based on its similarity to a reference biologic drug that was already ...
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Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a ...

--Samsung Bioepis Co., Ltd. and Organon& Co. today announced that the U.S. Food and Drug Administration has accepted for review the Supplemental Biologics License Application for the ...
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US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA™ (adalimumab-bwwd) Injection

“This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible. Both biosimilars and interchangeable biosimilars are highly similar and have no ...
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Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a ...

INCHEON, South Korea and JERSEY CITY, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the U.S. Food and Drug Administration (FDA) ...