(News Bulletin 247) – Sandoz, the biosimilar drugs subsidiary of Novartis, announced on Tuesday that the US Food and Drug Administration (FDA) has authorized the marketing of a new, more concentrated and citrate-free formulation of its generic version. of Humira.
This new formulation of the medicinal product under injection Hyrimoz has been authorized in the same indications as those of Humira, namely rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ulcerative colitis and psoriasis.
Sandoz states that the US health authority’s decision was based on clinical data showing that the product had the same efficacy and safety profile as Humira.
The Novartis subsidiary plans to market its new formulation of Hyrimoz in the United States from July 1st.
Originally discovered by AbbVie, Humira is a molecule resembling normal antibodies in the human body that works by inhibiting a protein that, when produced in excessive amounts, plays a key role in the inflammatory reactions of certain autoimmune diseases.
This ‘blockbuster’ has been approved in dozens of countries and prescribed to hundreds of thousands of patients.
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