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Pfizer's Humira biosimilar, 4 others backed for EU approval

The European Medicines Agency recommended the approval of five new therapies in December, including Amsparity, Pfizer Inc.'s biosimilar of AbbVie Inc.'s top-selling drug Humira.

Amsparity, or adalimumab, is intended to treat certain inflammatory and autoimmune disorders such as rheumatoid arthritis, psoriasis and Crohn's disease, among others.

The health agency's Committee for Medicinal Products for Human Use, or CHMP, also gave a positive opinion to Novartis AG's eye injection Beovu, or brolucizumab, for neovascular, or wet, age-related macular degeneration, a chronic eye disorder that causes blurry or wavy vision and could lead to blindness. The condition is due to the presence of abnormal blood vessels under the retina that leak fluid or blood into the macula.

The CHMP also backed the approval of Merck & Co. Inc.'s antibiotic drug Recarbrio — a triple combination medicine containing imipenem, cilastatin and relebactam — for infections due to aerobic Gram-negative organisms in adults with limited treatment options.

Also receiving the CHMP's backing were two generic medicines from Accord Healthcare SLU: Azacitidine Accord for blood cancers myelodysplastic syndromes, chronic myelomonocytic leukemia and acute myeloid leukemia — diseases that occur when the body produces large numbers of abnormal blood cells; and Dexmedetomidine Accord, to provide light to moderation sedation for adults in an intensive care unit.

Eight therapies were recommended by the regulator for extended indications, including new dose strength and intravenous administration of Helsinn Birex Pharmaceuticals Ltd.'s Akynzeo, a drug used to prevent chemotherapy-induced nausea and vomiting.

A combination of Eli Lilly and Co.'s Cyramza and erlotinib, sold by Roche Holding AG as Tarceva, was backed for extended approval as a first-line treatment of adult patients whose non-small cell lung cancer has spread into other parts of the body with activating epidermal growth factor receptor, or EGFR, mutations.

Johnson & Johnson and Genmab A/S' Darzalex, combined with chemotherapy drugs bortezomib and thalidomide plus corticosteroid medicine dexamethasone, was recommended for extended approval to treat adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant.

The CHMP recommended the broader use of three other Johnson & Johnson medicines: Erleada, with androgen deprivation therapy, for adult men whose hormone-sensitive prostate cancer has spread into other parts of the body; Sirturo to also treat pulmonary multidrug‑resistant tuberculosis in adolescents 12 years old to less than 18 years, weighing at least 30 kilograms; and Stelara to include children aged six years and older with moderate to severe plaque psoriasis.

The EMA also backed the extended approval of Pfizer's Vyndaqel, or tafamidis, to treat wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy, a rare and life-threatening heart disease. Cardiomyopathy is a condition that weakens the heart muscle, making it harder to pump blood throughout the body.

Astellas Pharma Inc.'s Dificlir was also recommended for extended approval to treat Clostridioides difficile infections, also known as C. difficile-associated diarrhea, in adults and children with a body weight of at least 12.5 kilograms.