The Hindu Business Line : Intas Bio plans Filgrastim launch in N. America, Europe

The Ahmedabad-based Intas Biopharmaceuticals Ltd (IBPL) has signed a business agreement with the Canada-based Apotex Inc for co-development and supply of its Filgrastim brand, Neukine, in North America (the US and Canada).

European pharmaceutical major Kwizda Pharma, which is working with IBPL to develop G-CSF for the European market, has transferred all of its rights in IBPL’s G-CSF to Apotex. Both Apotex and IBPL plan to launch Neukine in the US market, a company release said here.

Mr Mani Iyer, Executive Director, IBPL, said the two companies are eyeing a significant share of the total G-CSF market in North America and Europe, which is currently estimated to be around $1.4 billion annually.

Although guidelines for bio-similar product registration in North America are not yet finalised, the companies anticipate that there would be a clear pathway for biotech companies, once the related legislation is in place.

Intas is India’s only biopharmaceuticals manufacturing company to receive the EU – Good Manufacturing Practice certification. IBPL is the sole manufacturer of Pegylated GCSF in India and markets under the brand name Neupeg, the release added.

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