JERSEY CITY, N.J. & INCHEON, Korea--(BUSINESS WIRE)--Organon & Co. (NYSE: OGN) & Samsung Bioepis Co., Ltd. today announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab) ...

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 ...

“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 ...

Interchangeability study for HADLIMA (adalimumab-bwwd) was conducted in accordance with the FDA’s Guidance for Industry; primary pharmacokinetics (PK) endpoints as well as efficacy, safety and ...

In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars. Biosimilars with an interchangeable designation may be substituted for the reference product at ...

SPRINGFIELD, Mass. (WWLP) – Health New England announced Monday that it will shift coverage of the biologic drug Humira to more affordable FDA-approved biosimilars starting next month for members of ...

Please provide your email address to receive an email when new articles are posted on . Only half of rheumatologists are “extremely comfortable” prescribing the Humira biosimilar Amjevita, while just ...

Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 ...