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FDA approves Analog and Dipharma’s ANDA for nitisinone capsules

Pharmaceutical Technology

Dipharma is a pioneer in developing improved generic pharmaceutical products for rare diseases: our desire to innovate and our engagement do not stop, but every day we continue to seek new and better solutions for patients around the world.”

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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.

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FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device.

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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.

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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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Novartis’ Sandoz Launches Biosimilars Awareness Campaign to Improve Biosimilars Adoption Worldwide

XTalks

Sandoz is a pioneering leader in generic pharmaceuticals and biosimilars, as Sandoz launched the world’s first biosimilar in Europe in 2006 and won the first biosimilar approval in the US in 2014. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar.

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Excellence Awards 2022 – Winners Announced!

Pharmaceutical Technology

Sanofi wins the Product Launches award this year following the further development of its Dupixent (dupilumab) product and a string of approvals. In May the drug became the first medicine available in the US for eosinophilic oesophagitis following approval.

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