The coming revolution in much cheaper life-saving drugs

The recent FDA panel recommendation of approval for the first "biosimilars" to be available in the United States is expected to open the door to a new range of biosimilar drugs that will offer lower-cost competition.

The recent FDA panel recommendation of approval for the first "biosimilars" to be available in the United States is expected to open the door to a new range of biosimilar drugs that will offer lower-cost competition. No process for biologic imitators to compete with brand-name drugmakers existed until 2010, when a new regulatory pathway was authorized under the Affordable Care Act. For a drug to be deemed biosimilar, that law requires that the copycat drug is "highly similar" to the reference drug, and does not have "clinically meaningful" differences to it. "The FDA has to make a determination that it will behave the same way, it will have the same clinical profile," says Leah Christl, FDA associate director for therapeutic biologics. Biosimilar products on average will take 8 to 10 years to develop and cost the manufacturer between $100 million and $200 million. Though it is hard to predict what biosimilars will cost in the United States, they tend to cost about 20% to 30% less than the branded biologic in the overseas market that has existed for nearly a decade in the European Union and other countries.