Remove FDA Approval Remove Generic Pharmaceutical Remove Packaging
article thumbnail

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

The Pharma Data

“By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fueling pharmaceutical innovation.”. The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL.

article thumbnail

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

The Pharma Data

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL.

article thumbnail

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. The FDA approved the drug over a decade ago in September 2009. billion in 2022.

Sales 98