Medical device developer and manufacturer, BD (Becton, Dickinson and Company), has crossed the threshold into the pharmaceutical industry and formed the wholly-owned subsidiary BD Rx to develop, produce and market a new line of generic prefilled injectables.
Speaking with in-Pharmatechnologist.com, President of BD Rx Mark Sebree said BD was fully prepared to enter the area as it “already has a well-organized market presence” from its core device, instrument and reagent business.
BD will formulate and manufacture injectables entirely in-house from a newly built facility in Wilson, North Carolina, a decision that Sebree told us was “a natural extension” of its “prefillable syringe device.”
“We do think we can compete with the other players,” he continued, informing us that BD intended to “price the products at a level which will ensure responsibility and sustainability.”
BD’s entry into the market comes a month after Mylan acquired Agila for $1.6bn (€1.2bn), propelling the company into the top tier of generic injectable providers.
The company - which will discuss the new BD Simplist product line in a conference call scheduled for today - got the nod from the US Food and Drug Administration (FDA) on Tuesday when the regulatory body approved the company’s first therapy, Diphenhydramine Hydrochloride Injection, an injectable antihistamine. BD plans to launch between 20 and 30 products in the next few years.
Quality Concerns
The injectables market has recently had its fair share of issues relating to quality, many of which have caused drug shortages. Just in the last two months the industry has seen violations, contaminations and serious quality concerns from some of the biggest companies and manufacturers in the industry, including: Pfizer, Jubilant HollisterStier, Hospira, Nihon Pharmaceuticals and Ben Venue.
Sebree denied BD was entering the market in response to the rising problems. “Quality has always been a differentiator, even before recent drug shortages,” he said. “Our thinking has always been steeped in quality concerns but the path was embarked on long before the quality issues.”
He also cited a recent paper written by Director of the Center for Drug Evaluation and Research at the FDA, Janet Woodcook, who attributed much of the recent spate of drug shortages and quality issues to aging facilities, first used in the 1960s.
Therefore BD decided to go down the route of building a “completely new facility” so it “could be compliant with the highest standards possible.” The Wilson facility has been operational for a while and, following the FDA’s approval this week, is ready to begin full production.
Drug Delivery
“These new capabilities offer a real opportunity to advance the progress on how these types of drugs are administered,” Sebree added, continuing to say that the ease of use of the drugs would combat against potential risk of error.
The prefilled injectables will cut down the steps clinicians perform from 20 (with traditional syringe/vial technology) to approximately 12. This advance in drug administration is similar to BD’s ‘flush’ device line which changed the way drugs were delivered by IV lines and, according to Sebree “planted the seed of thought that BD can do the same” for fully formulated drugs.