Fiprima, a biosimilar of filgrastim, was approved by Brazil’s regulator, ANVISA, in late October. The drug increases the number of neutrophils (defensive cells) in patients whose immune systems has been damaged by chemotherapy of a bone marrow transplant.
Eurofarma’s Vanda Magalhães said it is the first time a Brazilian company has developed a biosimilar using domestic technology:
"We started the project in 2006. We developed and executed all phases of the procedure, from the construction of clone, process development to analytical methodology.
"Just to have an idea of the importance of this advance, there are only 20 biosimilar drugs in the world, one in the United States and another 19 throughout Europe, with the first one being approved in 2006."
South Korean Celltrion's biosimilar Remsima was approved by ANVISA this year, but Eurofarma claims its biosimilar is the first to be developed domestically.
Amgen owns comparator
Biologic costs are high everywhere, including Brazil where they make up just over half the Brazilian Ministry of Heath’s pharma spending, but represent only 4% of the volume of drugs distributed to the population.
Amgen owns the filgrastim originator, which it sells as Neupogen. Abbott, Dr Reddy’s and other companies also have rights to cell filgrastim in certain markets. This year, Sandoz launched the first biosimilar of filgrastim, Zarzio/Zarxio.
PDP
R&D for the drug cost R$25m (US$7m) and took nine years.
Under a PDP (Partnership for Productive Development) agreement, Europharma will supply the Brazilian health service with Fiprima. The company said it expects to produce 360,000 annual doses beginning in the first quarter of 2016.
The company reported revenue last year of R$2.6bn (US$700m).