Becton, Dickinson enters generic injectables market, with big plans for expansion

Slowly-turning wheels to address ongoing drug shortages—especially in the generic injectables segment—and a continuation of the trend away from vials and toward prefilled syringes come out of BD’s announcement that it has FDA approval to market the first of what it calls the Simplist family of products. The FDA-approved drug is diphenyldramine HCl, an injectable antihistamine. BD, based in Franklin Lakes, NJ, says this is the first of 20-30 drugs “over the next few years,” according to a company statement. BD also told the Wall St. Journal that it expects to generate $100 million by 2017—which might not sound like a lot, but would represent a substantial number of generic sales. Most of those new offerings will target injectables most commonly used in hospitals or surgical settings. Worldwide, on the order of one billion vials or prefilled syringes are sold annually.

According to various press reports, BD will be offering the Simplist line through a subsidiary, BD Rx, which has a new manufacturing facility in Wilson, NC. That facility is said to have 120,000 sq.ft. of manufacturing capacity, built at a cost of $108 million and completed in 2010. BD’s statement also emphasized the push for prefilled drug delivery, saying that the prefilled route saves some 20 steps for nurses or pharmacy technicians. The company has a long history in syringe applicators, vials, infusion systems and other forms of drug delivery. Prefilled syringes are generally safer for hospital personnel and patients, by avoiding potential cross-contamination and medication errors.

"The vial and syringe injection process is inefficient for healthcare workers," said Mark Sebree, President, BD Rx. "With the new BD Simplist ready-to-administer, prefilled injectables, BD is aiming to redefine injectable drug administration practice. BD envisions safe patient care and efficient clinical applications and believes this is the future of injectables."

Although not specifying which drugs will follow the diphenyldramine HCl entry, BD is capitalizing on the current problems experienced by several traditional generic injectables suppliers, including Hospira, Boehringer Ingelheim and Sandoz in recent years. In addition, the problems at compounding pharmacies like now-shuttered NECC and others highlight the current supply problems.