NEWS OF THE WEEK
PETER CUTTS PHOTOGRAPHY
OPTIMISM AMONG INSTRUMENT FIRMS
A marching band helped open the Pittcon show in New Orleans.
PITTCON: Despite currency concerns, toolmakers look for strong sales in 2015
NSTRUMENT FIRM executives at the Pittsburgh
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Conference on Analytical Chemistry & Applied Spectroscopy (Pittcon) last week said they want to see last year’s healthy sales pace continue into 2015. However, they are concerned about the impact the strong U.S. dollar will have on their bottom lines. “Business improved overall in 2014,” said Arthur G. Caputo, executive vice president of chromatography expert Waters Corp. But the strong U.S. dollar will likely have a negative impact on earnings, he cautioned. “We are all dealing with currency exchange issues,” noted Dan Shine, president of Thermo Fisher Scientific’s chromatography and mass spectrometry business. To offset the dollar’s 30% climb against the euro over the past year, Thermo Fisher will try to supply European customers from Asian instead of U.S. factories. Jon DiVincenzo, senior vice president of PerkinElmer, agreed that currency issues will pose a challenge. But on the positive side, he said sales in China could accelerate,
FDA APPROVES FIRST BIOSIMILAR PHARMACEUTICALS: Agency’s
decision paves the way for cheaper biological drugs
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HE FOOD & DRUG ADMINISTRATION has ap-
proved the first biosimilar product in the U.S., opening the door for lower cost, generic-like biological drugs to enter the market. The product, called Zarxio (filgrastim-sndz), was developed by Sandoz as a less expensive alternative to Amgen’s Neupogen (filgrastim), a biologic drug prescribed to boost white blood cells in cancer patients. Biosimilars are not exact duplicates of already approved biologic drugs. Rather, they are products that, when administered to people, behave in a highly similar manner to an already approved biologic drug. Unlike conventional small-molecule SANDOZ
Sandoz manufactures biosimilars at its Kundl, Austria, site.
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because a business slowdown stemming from internal government anticorruption actions appears to be over. Many tool suppliers used Pittcon, held in New Orleans, as an opportunity to trot out new laboratory software and as a showcase for miniaturization technology. PerkinElmer, back at Pittcon after a four-year absence, used the conference to exhibit tools including a high-end liquid chromatography system, the Altus UPLC, for industrial analysis. It’s controlled with Empower 3 software from competitor Waters. Other firms emphasized software to handle the everincreasing volume of data streaming out of analytical instruments. Waters showed customers its NuGenesis lab information management system, which it claimed is less cumbersome than competing systems. Thermo Fisher unveiled its AppsLab online database, which one executive called an “iTunes-like library for chromatography methods with a checklist for testing reagents.” Small but capable instruments and components also debuted. Florida-based BioTools demonstrated a family of portable Raman microscopes each weighing less than 40 lb. Texas Instruments offered spectroscopy module makers a microelectromechanical systems (MEMS) chip optimized for handheld devices. And Si-Ware Systems, an Egyptian semiconductor maker, brought out a complete module containing its MEMS chip for Fourier transform infrared spectrometers.—MARC REISCH
drugs, which can be easily copied, biologics are made with living organisms and thus vary from one batch to the next. Biologic products tend to be the drugs with high price tags, says John Jenkins, director of FDA’s Office of New Drugs. And they are one of the fastest-growing segments of the pharmaceutical market. Congress gave FDA the authority to approve biosimilars in 2010 under a provision of the Affordable Care Act that aims to boost competition in the biologics marketplace. “One of the goals is to see lower prices to make access better for the patients who need these products,” Jenkins says. To get biosimilars onto the market quickly, FDA developed a regulatory path that requires companies to submit fewer clinical and preclinical data for biosimilars than for new biologics. Manufacturers must show that there are no clinically meaningful differences between a biosimilar product and an already approved reference product for a particular indication. Filgrastim has been proven to have clinical value, “but it is underused in the U.S. for a variety of reasons, including price,” says Louis M. Weiner, director of the Lombardi Comprehensive Cancer Center at Georgetown University. “The approval of Zarxio may reduce costs to the health care system,” he says. FDA expects to approve other biosimilars in the near future. The agency has at least four applications under review.—BRITT ERICKSON
MARCH 16, 2015
