Hospira and Pfenex to Develop Biosimilar of Genentech’s Lucentis

Hospira is looking to add another biosimilar candidate to its growing pipeline by partnering with Pfenex to develop and market a biosimilar of Genentech’s retinal disease therapy Lucentis.

The deal calls for Hospira to pay Pfenex $51 million upfront, plus a one-time payment of up to $291 million and tiered double-digit royalty payments once the biosimilar hits the market. The agreement, which is still subject to regulatory approval, also leaves room for future collaboration on other products.

Hospira will share costs of the Phase III equivalence trial with Pfenex, a clinical-stage biotech company, and will manufacture and market the final product. Branded Lucentis (ranibizumab) had about $4 billion in global sales last year, the companies said.

The biosimilar, called PF582, is currently in a Phase 1b/2a clinical trial being conducted by Pfenex. That trial has 24 patients who have been randomly assigned monthly intraocular injections of the biosimilar or branded Lucentis.

The Lucentis biosimilar, if approved, will expand Hospira’s biosimilar pipeline into a new therapeutic area, says Sumant Ramachandra, senior vice president and chief scientific officer.  

Hospira is one of four biosimilars makers to have publicly disclosed a product filing with the FDA, although none has been approved. Hospira’s biosimilars pipeline is a significant draw in Pfizer’s planned $17 billion purchase of the injectables manufacturer, announced two weeks ago. — Bryan Koenig