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Amgen's breast cancer biosimilar, 5 other new drugs recommended for EU approval


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Amgen's breast cancer biosimilar, 5 other new drugs recommended for EU approval

The European Medicines Agency recommended approving six new medicines in March, including Amgen Inc. and Allergan Plc's Kanjinti, a biosimilar of Roche Holding AG's breast cancer drug Herceptin.

Kanjinti is indicated for use in breast and gastric cancer that has spread, as well as early breast cancer.

The agency's Committee for Medicinal Products for Human Use also granted a positive opinion to GlaxoSmithKline Plc unit ViiV Healthcare Ltd.'s Juluca, indicated for treating HIV infection.

The committee recommended granting conditional marketing authorization to Clovis Oncology Inc.'s Rubraca to treat relapsed or progressive ovarian cancer.

The EMA also backed the approval of another biosimilar: Novartis AG unit Sandoz's Zessly to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

Two generic therapies were also recommended for approval: Krka d. d.'s pemetrexed, a generic version of Eli Lilly and Co.'s Alimta to treat malignant pleural mesothelioma, a rare and malignant cancer caused by asbestos, and non-small cell lung cancer; and prasugrel, Mylan NV's generic copy of Daiichi Sankyo Co. Ltd.'s Efient to prevent blood clot in adult patients with acute coronary syndrome.

The panel also recommended approving Ipsen SA and Exelixis Inc.'s Cabometyx as a primary treatment for adults with certain types of advanced renal cell carcinoma, the most common form of kidney cancer.

The committee issued negative opinions for Portola Pharmaceuticals Inc.'s Dexxience, a drug intended to prevent blood clots from forming in the deep veins of the leg. The California-based company said it intends to appeal and request a re-examination of the opinion.

The panel also adopted a negative opinion on Radius Health Inc.'s osteoporosis medicine Eladynos.

After a re-examination, the committee maintainedits negative recommendation on Pharma Mar SA's blood cancer drug Aplidin.

Pfizer Inc. has also requested the re-examination of CHMP's negative opinion adopted in February for an expanded approval of its cancer drug Sutent to include treating patients whose kidney cancer is at a high risk of returning following surgery.

Elsewhere, Amgen withdrew its application for its drug Aranesp, which is intended to treat anemia in patients with myelodysplastic syndromes, a group of bone marrow disorders in which the bone marrow fails to produce sufficient healthy blood cells.