The market for biogenerics is intensifying as the US prepares a regulatory pathway, with other countries likely to follow its lead, and Hospira’s acquisition is intended to strengthen its position in the sector.
Dan Rosenberg, a company spokesperson, told in-PharmaTechnologist that the business will realise several benefits by acquiring full ownership of filgrastim, which was previously part of a strategic collaboration between Hospira and Pliva/Barr.
The deal eliminates the need to split profits and, with the acquisition of the Croatian facility, gives Hospira the capacity to produce filgrastim’s active pharmaceutical ingredient (API) and finished dosage form.
By adding the Croatian facility to its biologics manufacturing capacity, which includes an Escherichia coli production site and deals with Human Genome Sciences and Stada Bioceuticals, Hospira has the capabilities to meet its worldwide requirements for filgrastim and pegfilgrastim.
Rosenberg added that there is the possibility of expanding to provide additional biogenerics manufacturing. Hospira also provides fill-finish for biologic drugs on a contract basis.
Hospira intends to immediately launch filgrastim in new markets. Before the acquisition Hosipra had the rights market filgrastim in Western Europe and Australia but now intends to launch in the rest of Europe and other major countries in Asia-Pacific.
Launches in other markets will be evaluated prior to the close of the deal, according to Rosenberg. The market for branded filgrastim products was worth $1.8bn (€1.2bn) in 2008, according to Rosenberg, and by expanding Hospira intends to maximise its share of this.
Biogenerics have been identified by Hospira as one of its “growth drivers” and consequently is a focus of the company’s expansion plans and merger and acquisition strategy.
Rosenberg explained that Hosipira “would consider tuck-in acquisitions or partnerships that would support growth for these strategic areas of focus”, which includes biogenerics.