Sandoz receives “positive opinion” from EU

Sandoz has said it has received “positive opinion” from European regulators for its third biosimilar medicine, filgrastim.

The drug is for use in treating neutropenia, a condition as a result of a lack of neutrophils – a common type of white blood cell – that is often associated with bone marrow transplants or chemotherapy.

Chief executive officer Andreas Rummelt said the positive opinion is “an important first step towards EU regulatory approval”.

He added: “In addition to significant potential cost savings, our product offers patients and healthcare providers a very pure form of filgrastim.”

Last month, Sandoz was one of four companies sued by Lilly for the alleged filing of abbreviated new drug applications to make and sell Cymbalta (duloxetine hydrochloride) capsules, before the company’s patent expires in 2013.

The other three companies in the lawsuit were Cobalt Laboratories, Impax Laboratories and Wockhardt.

The drug was launched in 2004.

In 2007, Sandoz – a division of the Novartis group – employed approximately 23,000 people around the world and announced sales of $7.2 billion (4.81 billion pounds).

The company sells its products in more than 130 countries and has a portfolio of over 950 compounds.