On March 24, the French competent authority (ANSM) authorized Avastin®, as part of an TUA (Temporary Use Authorisation) in the treatment of macular degeneration related to age (AMD).
In France, two products are indicated : Lucentis (Novartis ) and Eylea® (Bayer). Avastin, whose cost is lower than the cost of the other two drugs, does not have this indication. He was prescribed off-label in many countries.
As we mentioned in the January issue of our Newsletter, this decision comes at a particularly competitive environment. Roche and Novartis have, indeed, been convicted of anti competitive agreements in several States and investigations are ongoing in others. These Laboratories have disseminated information to promote the sales of Lucentis at the expense of Avastin®, including reliance on artificial differences between the two products and suggesting that off-label use of Avastin, could present some risks, where Lucentis was developed by a subsidiary of Roche, who continues to receive royalties on sales of Novartis …
The evolution of the prescriptions will be decisive.