Findings from a randomized, double-blind, 3-arm, parallel biosimilarity study confirmed the safety, immunogenicity, and pharmacokinetics of Hyrimoz. The primary endpoint, bioequivalence for all ...

The US Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz. Sandoz said ...

"With the FDA approval of Hyrimoz, Sandoz is one step closer to ... and immunogenicity profile to the reference biologic.[2],[3],[4] Rheumatoid arthritis is among the most common types of ...

efficacy and quality of Hyrimoz against the reference product. Additionally, the FDA considered the results of the ADACCESS trial, a phase 3 randomized, double-blind, controlled, 51-week study for ...

(RTTNews) - Sandoz said that the citrate-free high-concentration formulation or HCF of its biosimilar Hyrimoz (adalimumab-adaz) injection will be available in the United States starting July 1.

BOUCHERVILLE, Quebec, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Sandoz Canada Inc. announced today the launch of Hyrimoz ® (adalimumab injection, reference biologic drug: Humira ®), which was authorized ...

(RTTNews) - Sandoz announced the European Medicines Agency has accepted the application for high concentration formulation 100 mg/mL of its biosimilar Hyrimoz for regulatory review. The company ...

Basel, April 3, 2023 — Sandoz, a global leader in off-patent (generic ... 100 mg/mL) of its biosimilar Hyrimoz ® (adalimumab). The approval includes all indications covered by the reference medicine*: ...