Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Roche’s Avastin is 1/30th of the the price of Novartis’ Lucentis:  off-label treat wet age-related macular degeneration (AMD) – FDA has not approved it for that use

Reporter: Aviva Lev-Ari, PhD, RN

The main rationale for using Avastin instead of Lucentis in patients with wet AMD is to save money. Both Avastin and Lucentis’ mechanism of action involves inhibition of vascular endothelial growth factor (VEGF). VEGF inhibitors reduce the growth of new blood vessels, including in the eyes, thereby decreasing growth of abnormal blood vessels in the central retina of patients with AMD.

The FDA has not approved Avastin for AMD treatment, nor does Roche recommend its off-label use.

Last September, France irked the pharma industry when its pharmaceuticals regulator put a law into effect allowing Avastin to be used to treat AMD. Avastin is considerably cheaper (1/30th of the cost) than Novartis’ Lucentis and other drugs indicated for treatment of AMD.

However, Avastin has not been tested for ophthalmic applications. In response to the situation in India, Roche noted using Avastin off-label risks contamination, as reported by Reuters.

As for Novartis, in November 2015, the Swiss company clarified its position on the Avastin versus Lucentis issue. According to a release from Novartis:

• Lucentis and Avastin are different molecules with distinct molecular and pharmacological profiles and are manufactured to different standards.
• Only Lucentis was developed for and is approved by regulatory authorities for use in the eye.
• Avastin is approved and manufactured for intravenous use in cancer patients.

The situation in India was serious enough to warrant surgery for all 15 patients. A week later, six of these patients are still in the hospital. Regulators in India are testing the Avastin used to see if it was a counterfeit version of Avastin.

SOURCE

http://www.biopharmadive.com/news/off-label-use-of-avastin-in-india-hospitalizes-15-sales-halted-in-two-stat/412349/