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

The Pharma Data

“At Sandoz, we are constantly looking for ways to meet the changing needs of patients and health care providers,” said Florian Bieber, Global Head Biopharmaceuticals Development, Sandoz. “By 2,3 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL.

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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). It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

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

XTalks

is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc.

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