Biosimilars, Packaging, Pharmaceuticals and Pharmacokinetics

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

Biosimilars

Packaging

Pharmaceuticals

Pharmacokinetics

Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

The Pharma Data

JUNE 17, 2022

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe.

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.

Drug Discovery Digest

Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

Stay Connected