Logo Informatori.Info

 

 

mag26

Sandoz’ MabThera biosimilar to get EU review


European regulators have agreed to review Sandoz' biosimilar to Roche's oncology/immunology blockbuster rituximab.

 

Rituximab is a monoclonal antibody, sold in Europe under the brand name MabThera, which is used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukaemia and autoimmune diseases such as rheumatoid arthritis.

Sandoz said it is seeking approval for the same indications as the reference product, and that it believes its product to be "highly similar" going on data from clinical trials involving more than 800 patients.

"Patients with haematologic or blood cancers and rheumatoid arthritis, as well as their doctors, often have few treatment options and have long relied on rituximab as a vital part of their treatment," said Richard Francis, Division Head and chief executive of Sandoz, a Novartis group.

While pricing details are a long way off, biosimilars are coming on to the market around 30 percent less than their reference products, and Francis noted that, "if approved, we believe our biosimilar rituximab will help broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines."

The filing of biosimilar rituximab marks the sixth of 10 the company is intending to submit over a three-year period (2015-2017).

26/05/2016 - Categoria: Farmaci - Da: Sh@wn - 304 letture

 

  Commenti

Nessun Commento.

Il tuo Nome
Email
Website
Titolo
Commento
Immagine CAPTCHA
Inserisci il codice

RITORNA ALLA PAGINA PRECEDENTE

Cerca un articolo

Argomenti
Skip Navigation Links.

AIFA

AIISF

Articoli Scientifici

ASL

Associazioni-Sindacati

Auto Aziendale

Aziende Farmaceutiche

British Medical Journal

Codice Strada

Congressi

Contravvenzioni

Dispositivi Medici

Enasarco

Eventi

Eventi ECM

Farmaci

Farmacie

Farmindustria

Faschim

Federaisf

Fonchim

Informatori

Jama

Lancet

New England

Parafarmacie

RSU Aziende

Sanita'

SLF Cobas

);