In this Issue

As 2016 drew to a close, the Food and Drug Administration gave a gift of sorts to drug makers looking to submit to the agency an application for approval of a biosimilar drug when it issued its final guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”

(To view the full Category Review, click here.)

The finalized guidance follows the draft guidance the agency issued in May 2014.

America’s selfie-, Instagram- and overall social media-obsessed habits are propelling growth of oral care products promising instant fixes.

(To view the full Category Review, click here.)

While the C/A/S tablet and liquid subcategories have seen little change in sales versus year-ago sales, the UR nasal subcategory saw impressive growth in the channels studied, due in large part to the recent Rx-OTC switch products in the nasal corticosteroid segment, driving sales up 15% in the food industry and up to10% in drug. (see Figure 1).

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Overall, the sale of all sleep remedies were up 6.1% to $707.9 million across total U.S. multi-outlets for the 52 weeks ended Nov. 27, 2016, according to IRI. Procter & Gamble’s ZzzQuil still leads the category. Sales of the liquid formulation are outpacing category growth with an uptick of 8.4% to $85.3 million, or 12% of total category sales.

(To view the full Cough-Cold Report, click here.)

Diabetes has become a worldwide epidemic. According to data recently published by the Brussels-based International Diabetes Federation, by 2040 more than 642 million people worldwide will suffer from diabetes, up from 415 million in 2015, the last year for which the organization has statistics. In North America, this figure is expected to jump from the current 30 million cases to around 41 million.

(To view the full Category Review, click here.)

Generics have made a huge difference to the U.S. healthcare system’s bottom line in the past decade, a savings that takes 13 figures to tabulate.

(To view the full Category Review, click here.)

Increasingly, pharmacies are turning to automation as a way to increase efficiency and free up their pharmacists — employing everything from lower-cost, in-store automation to sophisticated robotics systems that help make central fill operations more efficient and reduce dispensing costs.

(To view the full Category Review, click here.)

Last year, Drug Store News projected that GSK Consumer Healthcare’s Flonase allergy franchise would be challenged with the introduction of two new nasal corticosteroids to the market — McNeil Consumer’s Rhinocort and Bayer’s ClariSpray.

(To view the full Cough-Cold Report, click here.)