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Pfizer's copy of Roche's Avastin, 6 other drugs recommended for EU approval

The European Medicines Agency recommended the approval of seven new therapies this month, including Pfizer Inc.'s Zirabev, a biosimilar of Roche Holding AG's cancer drug Avastin.

Biosimilars are intended to be lower-cost versions of biologic therapies. Avastin is approved in the U.S. and elsewhere for a number of cancers, including brain cancer, colorectal cancer, non-small cell lung cancer and cervical cancer.

AOP Orphan Pharmaceuticals AG's Besremi and medac GmbH's Trecondi — both orphan drugs — also received positive opinions from the regulator's Committee for Medicinal Products for Human Use, or CHMP, the agency said in a Dec. 14 statement.

Besremi is a treatment for polycythaemia vera without symptomatic splenomegaly, a bone marrow disease. Trecondi is a conditioning treatment for patients before they undergo allogeneic hematopoietic stem cell transplantation — a procedure in which a patient receives healthy stem cells, usually as a treatment for cancers of the blood or bone marrow.

The EMA also recommended granting a marketing authorization to Shionogi & Co. Ltd.'s lusutrombopag, sold under the brand name Mulpleta, for treating severe thrombocytopenia, or low platelet count, in adults with chronic liver disease who are undergoing invasive procedures. Shionogi's Rizmoic was also granted a positive opinion as a therapy for opioid-induced constipation.

Additionally, the CHMP granted a positive opinion for PARI Pharma GmbH's tobramycin, a hybrid medicine intended to treat chronic pulmonary infection due to Pseudomonas aeruginosa, a disease-causing bacterium, in cystic fibrosis patients aged 6 years and above.

Dipharma's generic miglustat was also recommended for treating adults with mild to moderate type 1 Gaucher disease, a rare genetic disease resulting from the deficiency of an enzyme called glucocerebrosidase.

Pfizer withdrew its application for Fyzoclad, a biosimilar to AbbVie Inc.'s top-selling drug Humira, or adalimumab. Humira is a treatment for various inflammatory diseases, including types of arthritis, psoriasis and uveitis.

Novartis AG also pulled its application seeking marketing authorization for its drug Ilaris, or canakinumab, which the Swiss drugmaker markets in the U.S. for treating arthritis and autoinflammatory diseases.

Meanwhile, the CHMP also recommended extending the indication of 6 medicines, including Clovis Oncology Inc.'s Rubraca to include use as a maintenance treatment in adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors shrank following platinum-based chemotherapy.

The London-based EMA makes recommendations to the European Commission, which ultimately decides whether to approve or reject manufacturers' applications for marketing approval in the EU.