The first drug of its kind was just approved, and it could signal a massive change for pharmaceuticals
REUTERS/Arnd WiegmannThe logo of Swiss drugmaker Novartis is seen at its headquarters in Basel October 22, 2013.
US regulators on Friday gave a green light to sales of the country’s first copied version of a biotechnology drug, or “biosimilar,” with approval of Novartis’ white blood cell-boosting Zarxio.
The Affordable Care Act provided a pathway to approval for such drugs, which are often cheaper approximations of extremely expensive pharmaceuticals. Biosimilars have the potential to save the healthcare system billions, according a RAND Corporation analysis.
Jason Millman of The Washington Post explains why we don’t see generics of some of these newer, often astronomically expensive drugs, called “biologics:”
Biologics are more complex than traditional drugs made from synthetic chemicals. They’re made from living organisms, so they can’t be exactly replicated by another product. Instead, the biosimilar manufacturer has to prove that its copycat product is similar enough in safety and effectiveness.
Even though biosimilars are not as deeply discounted as traditional generics, for patients with complex diseases like arthritis and some cancers, Millman notes, they stand to “save thousands of dollars” if biosimilars become available for the biologics they are treated with.
Pharmaceutical companies also see biosimilars as a major opportunity — a fresh stream of revenue when the patents on these newer drugs out. “Innovative biotechnological companies have been enjoying bonanza times since the biodrug discoveries of the 1990s,” researchers wrote in the journal Pharmaceuticals. “However, the market value captured by these companies is under threat due to the imminent biologics patent cliff.”
The US is expected to see many more drugs that follow this route, but Zarxio is the first such biosimilar approved here.
The drug contains the same active ingredient as Neupogen, or filgrastim, which logged 2014 worldwide sales of $1.2 billion for manufacturer Amgen. It helps patients undergoing cancer treatment fight off infections.
The Food and Drug Administration (FDA) said it approved Zarxio for treating the same five conditions for which Neupogen is used.
The move had been expected after Zarxio, which is made by Novartis’ generics unit Sandoz, won unanimous backing from an FDA panel in January.
(Reporting by Ben Hirschler. Editing by Jane Merriman)