Hospira Announces U.S. Launch of Generic Bivalirudin for Injection

LAKE FOREST, the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, today announced it had obtained U.S. Food and Drug Administration (FDA) approval for the launch of bivalirudin for injection, a generic version of The Medicines Company's Angiomax™. Branded sales of Angiomax in 2014 in the United States were approximately $500 million.  

Hospira's bivalirudin for injection is available in a single-dose flip-top vial, which matches the current branded offering available. In addition, the company plans to launch a differentiated presentation of the 250 mg bivalirudin for injection in Hospira's unique ADD-Vantage™ vial.

"Hospira is excited to launch the first generic of bivalirudin based on a successful challenge of the originator's patents," said Philippe Drouet, president, U.S. Commercial, Hospira. "This approval further demonstrates our commitment to bringing safe, lower-cost generic versions of important medications to the market as soon as possible."

Available as a lyophilized (powder) format, Hospira's bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients: 

• With unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA); 
• Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study; 
• With, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI. 

Bivalirudin is intended for use with aspirin.     

Hospira's specialty injectable pharmaceuticals (SIP) offering includes approximately 200 generic injectable drugs in many dosages and formulations. In addition, many of its products are available in popular differentiated presentations, several of which are proprietary, such as the ADD-Vantage™ drug delivery system and Carpuject™ prefilled syringes. Therapeutic segments include analgesia, anesthesia, anti-infectives, cardiovascular, oncology, emergency and other areas. Hospira also has robust pipelines of both generic and biosimilar drugs.

Important Safety Information

Contraindications

• Active major bleeding. 
• Hypersensitivity to bivalirudin or any product components. 

Warnings and Precautions

• Bleeding events: Hemorrhage can occur at any site. Discontinue bivalirudin for an unexplained fall in blood pressure or hematocrit. 
• Coronary artery brachytherapy: Risk of thrombus formation, including fatal outcomes, in gamma brachytherapy. 

Adverse Reactions 
Most common adverse reaction was bleeding (28 percent). Other adverse reactions (incidence >0.5 percent) were headache, thrombocytopenia and fever. 

Limitation of use
Safety and effectiveness has not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.

Source: Hospira, Inc.