Hospira continues to forge a new market reality around biosimilars, capturing wide swathes of market share with deep discounts for its biosimilar of Merck's arthritis blockbuster Remicade. Hospira has reportedly captured a public contract in France by offering a price that amounts to a 45% savings.
After dealing with two preapproval inspections and two dozen FDA observations, injectables specialist Hospira says it has gotten FDA approval and is ramping up production at its new plant in India.
The game is on at Hospira's massive new manufacturing plant in India. After two delays to work out kinks identified by the FDA, the drugmaker says the agency has signed off on it and Hospira has started "limited commercial production at the facility."
Two months ago, the FDA issued a warning letter for a Hospira plant in Italy noting a number of problems including its lack of controls for access to prevent data deletions from test equipment. Health Canada has decided that issue is enough for it to ban products coming out of the sterile manufacturing facility.
It's been more than a year since cybersecurity guru Billy Rios flagged Hospira's PCA 3 Lifecare infusion pumps for its poor cybersecurity. The issues have gone unaddressed, Rios says in a critical blog post, writing "we have yet to see a single fix for the issues affecting the PCA 3."
South Korea's Celltrion and Samsung Bioepis are poised to gain new or expanded approval for biosimilars of some of the world's best-selling biological drugs, setting up a regulatory knowledge base on approvals and bringing commercial competition to major drugmakers not unlike that seen by small-molecule generics from India decades ago.
A study released today that pitted Hospira's biosimilar Inflectra against its reference drug Remicade in patients with rheumatoid arthritis is good news for Hospira, and by default Pfizer. It found that patients who were switched to the copy did just as well, with no unexpected side effects, as they had on Merck and Johnson & Johnson's Remicade.
Hospira recalled more than 60 lots of the pain reliever ketorolac tromethamine injection in January because of the potential for crystals in the 18 million vials that had been shipped in the U.S. and Singapore.
Hospira is voluntarily recalling 181,704 bags of magnesium sulfate in 5% dextrose injections because labels on the immediate container may have barcodes indicating that it is instead the blood thinner heparin.
The Department of Homeland Security warned that due to a cybersecurity flaw, a low-skilled remote hacker could alter the configurations of Hospira's LifeCare PCA Infusion System.