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EMA backs approval of Amgen's Humira biosimilars, Pfizer's arthritis drug


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EMA backs approval of Amgen's Humira biosimilars, Pfizer's arthritis drug

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended two biosimilars to AbbVie Inc.'s Humira for approval at its January meeting.

Amgen Inc.'s Humira biosimilar medicines Amgevita and Solymbic have been recommended for the treatment of certain inflammatory diseases.

The committee also recommended granting a marketing authorization for Pfizer Inc.'s Xeljanz for the treatment of active rheumatoid arthritis. Xeljanz in combination with methotrexate, a chemotherapy agent, will be indicated for the treatment of the disease in adults who have failed to respond adequately or are intolerant to one or more disease-modifying anti-rheumatic drugs, if approved.

Pfizer's marketing application is a resubmission. The committee rejected company's original application in 2013 as it did not demonstrate a favorable risk-benefit profile.

The recommendation on Xeljanz will now be sent to the European Commission, which grants marketing authorizations for centrally authorized medicines, for final decision.

The committee also had a positive opinion on informed consent applications of GlaxoSmithKline PLC's Rolufta for the treatment of chronic obstructive pulmonary disease, and Eli Lilly & Co.'s Tadalafil Lilly to treat erectile dysfunction and symptoms of benign prostatic hyperplasia, enlargement of prostate gland.

On the generic medicines front, Daptomycin Hospira was recommended for the treatment of complicated skin and soft-tissue infections, right-sided infective endocarditis due to staphylococcus aureus and staphylococcus aureus bacteremia associated with the diseases. The drug is from Pfizer's subsidiary Hospira UK Ltd.