Robert Wessman, the Icelandic entrepreneur who built Actavis into a generics powerhouse and then sold out, has decided get into the biosimilars business. He has talked his home country into helping finance his plans.
Hospira and its biosimilar partner Celltrion won European approval for the first biosimilar of a monoclonal antibody therapy in September when t he EU signed off on their Inflectra, a biosimilar of Johnson & Johnson's Remicade. But despite the achievement, the partners still face a huge challenge: getting doctors to use the drug.
Hospira's long-troubled infusion pump business is dealing with another recall, earning the FDA's most severe warning over a device malfunction the agency said can lead to serious injury and death.
When Hospira CEO F. Michael Ball discussed efforts to fix manufacturing quality failings in 2012, he warned the remediation project was likely to uncover a few "gators." In the end, Hospira found itself with a whole new swamp--on the device side of the business--but now believes it is nearing the end of its pharma fixes.
Hospira has been investing heavily in its massive Rocky Mount, NC, plant in an effort to get its product quality up to FDA expectations. Part of the $200 million being spent went into a quality and analytical testing laboratory where 200 people will work.
The Hatch-Waxman Act shook up the generic drugs business in 1984, and almost 30 years later, it's safe to say the law had its desired effect. About 84% of the 4 billion prescriptions written each year are for generic drugs, saving patients and government programs billions of dollars a year. In other words, generic drugs are big business. And with a slew of blockbuster brands now off patent, it's a big business with growing pains.
The legal question of whether patients can sue drugmakers when they can't get a med has come to a close. The case of a Florida woman who claimed she is now blind in one eye because of a shortage of Hospira drug Aquasol A has fallen just short of the Supreme Court.
Hospira is going through another vial problem. It is recalling three lots of drugs because of the potential for glass particles getting into them.
Sterile drugmaker Hospira recently recalled a lot of a parenteral nutritional product after a human hair was found in it. Now, the drugmaker is expanding a voluntary, nationwide recall of bupivacaine injection because particles of stainless steel and iron oxide were found in some vials.
Hospira, which jumped early into the the biosimilar market in Europe, has seen its efforts pay off with the approval of Inflectra, a biosimilar of Johnson & Johnson's Remicade.