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Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation

The Pharma Data

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira ® * (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. Source link: [link]

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

The Pharma Data

The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL. 2,3 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL. Our ambition is to be the world’s leading and most valued generics company.

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

The Pharma Data

The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL. 1 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL. About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars.

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Excellence Awards 2022 – Winners Announced!

Pharmaceutical Technology

The category crosses over with many of our other categories and can include new products, novel product features, new business practices, new marketing and sales strategies and more. Sanofi wins the Product Launches award this year following the further development of its Dupixent (dupilumab) product and a string of approvals.

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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. Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023.

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