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 ...

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) ...

Credit: FDA. The approval was based on data from a phase 1 study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of Hadlima 100mg/mL to 50mg/mL. The Food and Drug ...

Intended to fit into a patient’s lifestyle, HADLIMA is available in both a pre-filled syringe and autoinjector option. The HADLIMA TM PushTouch™ Autoinjector was specifically designed ...

“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 ...

HADLIMA is available in both a pre-filled syringe and PushTouch autoinjector option. The autoinjector was specifically designed with the patient in mind, with a thin 29G needle, a latex-free needle ...

--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 (adalimumab-bwwd) was first approved by the FDA in July 2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector. The high-concentration (40 ...