FDA will consider approval of biosimilar drug for first time

BY Hannah Yi  July 26, 2014 at 2:37 PM EST

Americans are a small step closer to accessing less-expensive specialty drugs known as biologics.

The Food and Drug Administration for the first time accepted an application for the approval of a copycat “generic” version of the brand name drug Neupogen, which treats patients with low white blood cell counts.

Sandoz, the generics company that submitted the application for filgrastim, already sells the cheaper biosimilar drug in more than 40 countries outside the U.S.

Biologics are a class of injectable drugs that are made from living cells, which makes them more complex to produce than traditional pills that are made by mixing chemicals.

Some popular biologics include Humira or Enbrel, used to treat rheumatoid arthritis, and Lucentis for macular degeneration.

Americans have been paying more for these injectable biologic drugs compared to patients in Europe or Asia because not a single “generic” version of these drugs – also known as biosimilars – has hit the U.S. market.

Biosimilars have been available abroad for nearly eight years and at a much lower price, often 30 percent less than the brand name version.

Earlier this year, we spoke to a patient from New York whose single injection of the biologic drug Procrit, which boosts red blood cells, cost $1,500. He needed the shot each week and that meant under his insurance plan his co-pay ended up being nearly $800 a month.

Despite the increasingly popular use of biologics in the country, the FDA does not yet have a regulatory system set up to approve lower priced “generic” biosimilars. However, the passage of the Affordable Care Act in 2009 aimed to change that by authorizing the FDA to set up that approval process.

And so the FDA’s review of this first application has been nearly five years in the making. The delay stems from concerns that biosimilars – because they’re more complex to produce – should be approached with a different regulatory system than the one in place for traditional chemical pills.