Co-operation on three continents boosts biosimilar G-CSF

A biosimilar protein that can be used to treat neutropenia is to be developed by Apotex, of Canada, in collaboration with Intas Biopharmaceuticals (IBPL), of India.

Neukine, a recombinant granulocyte colony stimulating factor (G-CSF), is already manufactured and marketed in India by IBPL. Austrian company Kwizda Pharma had been working with IBPL to develop G-CSF for the European market for some time. With immediate effect, Kwizda Pharma has transferred all of its rights in IBPL's G-CSF to Apotex. Apotex and IBPL have concurrently agreed to extend the collaboration to development of G-CSF for North America.

"It is part of Kwizda Pharma's current business strategy to work together with non-European pharmaceutical companies to break into the European market," said Dr Helmut Brunar, vp research and business development at Kwizda Pharma. "That is why we worked with IBPL to successfully complete a phase I clinical trial and have transferred our rights in IBPL's G-CSF to Apotex, including initiation of a phase III trial for the approval of G-CSF in Europe."

The agreement represents an important milestone for Apotex, as it strengthens the organisation's development in Europe and will offer support for entering this market with future biosimilar products currently in its development pipeline, according to Dr Jeremy B Desai, Apotex executive vice president, research & development.

"IBPL and Apotex are eyeing a significant share of total G-CSF market in North America and Europe, which is currently estimated to be around US$1.4bn (Euro 12m) annually," said Shri Mani Iyer, executive director, IBPL. Although guidelines for biosimilar product registration in North America are not yet finalised, the companies anticipate that there would be a clear pathway for biotech companies once the legislation is in place and are keen to explore opportunities for more biosimilar products in the future.