Legal Magazine

Change in Brazilian Law Broadens Market for Biologics

Posted on the 16 August 2016 by Angelicolaw @AngelicoLaw

In late 2015, drug developer Europharma received regulatory approval for Fiprima, a drug that helps patients with compromised immune systems as a result of chemotherapy used during cancer treatment. Brazilian drug regulator ANVISA reviews many new drugs each year, but Fiprima broke new ground. The drug marked the first time domestic drug production technology was used to produce a biosimilar – a copy of a biological drug, BioPharma Reporter explains.

When patents on brand name drugs expire, competitors use the same active pharmaceutical ingredient to enter the market with their version of the drug, often referred to as a generic. Biologics, however, are harder to copy because they are made from cells or proteins derived from living tissue. Yet newer drug making technology has now enabled competitors to make drugs that are comparable to biologics.

Because biological cells and proteins are unique, the copied versions are not exact copies. They are biologically similar, hence the term biosimilar. Such drugs are still rare. Europharma executives say there are only 20 biosimilars in the world and just one in the United States. Europharma’s Fiprima is a copy of an Amgen drug marketed under the name Neupogen.

The Brazilian market opened to generic drugs through legislation passed in 1999. It was intended to support local drugmakers and improve the trade balance of pharmaceuticals and active pharmaceutical ingredients, explains Practical Law. Though biosimilars date to 2002, the new legal framework governing these drugs was not established until 2010.

According to BioWorld, biologics represent 61 percent of the Brazilian government’s total annual spending on drugs. Government officials hope that biosimilars can help curb rising costs to the country’s public healthcare system. Just as generic drugs are less expensive than the original pharmaceutical they are based on, biosimilars cost less than original biologics.

Once a biosimilar is approved for use in Brazil, the healthcare system will cease purchasing the original drug and purchase the less expensive biosimilar instead. According to the Generics and Biosimilars Initiative, Brazil’s Ministry of Health hopes to save as much as $225 million annually by encouraging pharmaceuticals to make these drugs in Brazil for the Brazilian market.

Cost savings to the healthcare system are a long-term goal. To reach that goal, the Brazilian drug market must form a biologics market of its own. Lawmakers have created the legal framework to foster biosimilar development; now it is up to drug companies to pursue the science to make them.


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