Teva Pharmaceutical has been given a green light by the European Commission (EC) for Lonquex, a rival to Amgen's blockbuster Neulasta.
Lonquex (lipegfilgrastim) has been approved to reduce the duration of neutropaenia (low white blood cell counts) and febrile neutropaenia in patients undergoing cytotoxic chemotherapy for cancer, and is given as a single subcutaneous dose per cycle of chemotherapy.
Like Neulasta (pegfilgrastim), Lonquex is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) and is dosed at the same frequency as Amgen's drug.
It will compete head-to-head with Amgen's G-CSF franchise, which also includes and short-acting variant Neupogen (filgrastim) and had combined 2012 sales of $5.4bn, with Neulasta accounting for the bulk of total. Teva already markets a biosimilar version of filgrastim in both Europe and the US.
The drug was approved as a novel medicine rather than as a biosimilar, and completed a full phase III trials programme, which showed that it was comparable to pegfilgrastim in terms of both safety and efficacy when used to shorten the duration of neutropenia after cancer chemotherapy.
"This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer," commented Rob Koremans, chief executive of the division. Lonquex is the first biologic medicine from Teva's branded medicines division to be approved for marketing.
The EU approval has come earlier than expected, he added, at just eight weeks after the Committee for Medicinal Products for Human Use (CHMP) delivered a positive opinion on the Teva's marketing application.
Teva's biologics pipeline also includes reslizumab, a monoclonal antibody targeting interleukin-5 (IL-5) in phase III for moderate-to-severe asthma, and an albumin-fused G-CSF called balugrastim which like lipegfilgrastim is described by the company as a 'biobetter'.