Becton Dickinson (BD) won FDA approval yesterday for the first in its series of BD Simplist™ ready-to-administer line of prefilled syringes containing generic injectables.
The injectable antihistamine Diphenhydramine Hydrochloride Injection, USP will be the first product launched by BD Rx, a wholly owned BD subsidiary focused on commercializing and manufacturing prefilled injectables.
BD Rx plans to launch “20 to 30” BD Simplist prefilled injectables over the next “few” years, the company stated, adding that the subsidiary “is targeting injectable drugs in doses most commonly relied on by clinicians in both the hospital and surgical center settings.”
“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,” BD Rx president Mark Sebree said in a statement.
The company said its method of making injectables will make medication errors 17 times less likely than the traditional vial and syringe method, in which clinicians perform up to 20 steps to fill and inject a syringe.
William A. Kozy, BD’s executive vp and COO, said in the statement that BD made a “significant” investment in R&D and manufacturing capabilities in recent years by building a manufacturing facility for BD Rx that combines drug formulation with its manufacturing expertise. That facility is in the city of Wilson, NC, where BD opened a $108.6 million, 120,000-square-foot plant in 2010.
“BD is well positioned and uniquely suited to take this next step based on our demonstrated, 12-year history of continuous, reliable supply of our Flush products and existing leadership position in prefillable syringe manufacturing,” Kozy added.
BD is among companies clawing for a share of the injectable drugs market, estimated at $7 billion. Hospira is trying to persuade FDA it has addressed substandard manufacturing practices at its injectables plant in Rocky Mount, NC, though a reinspection earlier this month yielded a letter expressing 20 concerns, three of them expressed earlier. Hospira is faring better in India, where the company is building a $275 million plant as part of a company-wide increase in manufacturing capacity designed to produce more injectables.
Also in India, Agila Specialties is being acquired by Mylan, which has said it expects as a result to double to 116 its number of FDA-approved generic injectables. And in October, Teva Pharmaceutical Industries opened a $110 million plant opened in Gödöllo, Hungary, capable of producing up to 200 million units of injectable medicines.
BD Simplist prefilled injectables will not have a material financial impact in the fiscal year ending September 30, 2013, and was contemplated in BD’s earlier-announced FY ’13 guidance, the company stated. BD projected 6% to 6.5% growth in earnings per share in 2013, to $5.69 to $5.72 per share—a forecast raised in February from the initial range of $5.58 to $5.64 per share, following strong Q1 results.