The FDA has expanded the interchangeable designation for Yuflyma (adalimumab-aaty), a biosimilar to Humira, to include all presentations.

The Food and Drug Administration has designated Hadlima (adalimumab-bwwd) an interchangeable biosimilar to Humira (adalimumab).

Humira (adalimumab) is a prescription drug used to treat hidradenitis suppurativa (HS). It helps reduce moderate to severe symptoms of this condition. Humira is also available in biosimilar forms.

Switching to Humira biosimilars saved Navitus clients more than $315 million in upfront costs in 2024 and resulted in a 60% ...

Samsung Bioepis and Organon shared that the Food and Drug Administration has designated the Hadlima (adalimumab-bwwd) high- ...

In an interview, James D. Chambers, Ph.D., from Tufts Medical Center, talks about the factors that are impacting the ...

EMA advisors at the Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s adalimumab Humira biosimilar under three brand names – Halimatoz, Hefiya and Hyrimoz. The firm ...

With this approval, YUFLYMA is now fully interchangeable with the reference product, Humira ® (adalimumab), across all marketed dosage forms and strengths. YUFLYMA is a high-concentration ...

of Humira (adalimumab) 1,2 The interchangeability designation for HADLIMA is based on a Pharmacokinetics, Efficacy, Safety, and Immunogenicity study of SB5 versus Humira in patients with moderate ...

Organon and Samsung Bioepis' HADLIMA granted FDA interchangeability designation approval for all high- and-low concentration presentations.