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FDA’s approval of biosimilar drug opens way for savings

Zarzio could end up being the most notable drug of 2015, and not just for the people who take it. The medicine — which helps cancer patients undergoing chemotherapy to fend off infections — last week became the first so-called biosimilar to win Food and Drug Administration approval. Biosimilars are near-perfect copies of brand-name biotech drugs, complex medicines that are produced in living organisms such as cells and bacteria. This class of drug has the potential to transform the pharmaceutical field and, at the same time, bring about desperately needed savings in health care costs.

For years, the notion that biotech treatments could be mimicked precisely enough to pass muster was considered improbable. Advancements in science changed that. Europe has allowed the sale of Zarzio since 2009, but US regulators were slower to establish a pathway that allows manufacturers to bring biosimilars to market.

Zarzio’s introduction — primarily as a competitor to the Amgen blockbuster Neupogen — marks a milestone, and could add up to savings of $6 billion over the next 10 years, according to drug benefit manager Express Scripts. But that’s just the start — Express Scripts estimates that if 11 other biosimilars pass muster with the FDA, they would shave $250 billion off spending on comparable existing biotech drugs over that same period. Troyen Brennan, chief medical officer for CVS Health, told the Reuters news service Thursday that if enough biosimilars are able to compete with brand-name speciality therapies, prices could drop by 40 to 50 percent. That’s less than the 80-to-90 percent cuts that traditional generics typically yield, but substantially more than what some analysts projected immediately after Zarzio was approved.

Biosimilars arrive in the United States at a time when efforts to control health care expenses are gaining increasing attention and traction. This week, another Express Scripts report said spending on prescription drugs in the United States rose by about 13 percent in 2014, the most since 2003. Tellingly, much of the increase was tied to new speciality drugs. One in particular, Gilead Science’s Sovaldi, overwhelmed insurers and Medicaid providers. The pill effectively wipes out the hepatitis C virus — which affects about 3.2 million people in the US alone — but at a hefty price. Sovaldi went on sale at $1,000 a pill; $84,000 for a full course of treatment. The demand for the breakthrough treatment led some insurers to limit who could get it. Since then, other highly-effective hepatitis C drugs have entered the market, and insurance companies have negotiated discounts to ease some of the economic pressure.


The Boston area will likely play a key role in the future of biosimilars. The region is, by many measures, the nation’s top biotechnology hub. It’s a magnet for researchers, startups, US industry pillars, and global giants. Every day, companies from Kendall Square to the Innovation District are working on experimental drugs that have the potential to change or extend lives. Eventually, those drugs will come off patent protection and, ideally, face competition from biosimilars. That’s a tantalizing prospect. Imagine saving lives and money at the same time.