Autoinjector recognized by the Arthritis Foundation with Ease of Use Certification Individualized patient support program “HADLIMA For You” available including co-pay support Designed to improve ...

The Food and Drug Administration (FDA) has approved Hadlima (adalimumab-bwwd; Samsung Bioepis), a biosimilar to Humira (adalimumab; Abbvie). The Food and Drug Administration (FDA) has approved Hadlima ...

Please provide your email address to receive an email when new articles are posted on . The FDA has approved the fourth biosimilar to adalimumab, adalimumab-bwwd, for all eligible indications of the ...

--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 ...

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 ...

Samsung Bioepis and Organon shared that the Food and Drug Administration has designated the Hadlima (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 ml, 40 mg/0.8 ml) autoinjectors and ...

The FDA has approved Hadlima, a biosimilar to AbbVie’s blockbuster rheumatoid arthritis treatment Humira. However, it won’t be available in the U.S. until June 2023. The delayed launch date is a ...

The US Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner ...

sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued ...

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) ...