Biosimilars

A rose is a rose is a rose, and ibuprofen is ibuprofen no matter what generic-drug company makes it. The chemicals in one batch are identical to chemicals in another. Many new drugs, however, aren’t mixtures of chemicals produced by recipe but are organic substances such as hormones, antibodies and other proteins. They’re called biologics and are generally produced within genetically engineered cells that in effect become factories. Because each biologic drug can be traced back to a single cell, no two versions are ever exactly alike; a generic version can be similar to the branded equivalent, but never exactly the same. That’s why they’re called biosimilars. That’s also left U.S. regulators with thorny questions about what’s in a name — questions that are as much economic and political as scientific. At stake is the potential billions of dollars American consumers could save if biosimilars cut into the market share of drugs that cost as much as $150,000 a year per patient.

Years after sales began in Europe, Japan, Australia and India, the first biosimilar reached the U.S. market in September 2015, when Novartis began selling an imitation of Neupogen, a biologic made by Amgen that helps cancer patients increase depleted white blood cells — an estimated $1.2 billion product in 2014. The new drug, Zarxio, had been approved by the Food and Drug Administration in March. In the four years after the Affordable Care Act opened the door to biosimilars in 2010, an estimated 14 applications were submitted to the FDA. Heavy lobbying is still underway on the question of whether biosimilars can be sold under the name of the active ingredient in the original drug, the way generics are. That’s the case in the European Union but not elsewhere. To avoid global confusion, the World Health Organization has proposed creating a standardized set of biosimilar codes,, which countries taking different approaches on naming can all draw on. In a sign of how attractive the field is becoming, in February 2015 Pfizer said it would spend $17 billion to buy Hospira, a company focused on biosimilars.