Roche against biosimilars: MabThera SC now approved in EU

January 31, 2014 12:48 PM

Last week, CHMP recommended EU approval of a new subcutaneous formulation of Roche’s MabThera for patients with non-Hodgkin lymphoma.

Subcutaneous formulation to be administered under the skin over approximately five minutes compared with 2.5 hours with the current intravenous formulation.

Roche announced last week that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL).

“We are excited the MabThera SC data confirm the efficacy and safety of a significantly shortened treatment time,“ said Sandra Horning, M.D., Chief Medical Officer and Head, Global Product Development. “We are confident that reducing treatment to approximately five minutes with MabThera SC will be an improvement for patients and healthcare professionals alike.”

Currently, MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. The new MabThera SC formulation can be delivered over approximately five minutes and comes as a ready-to-use, fixed dose, which reduces pharmacy preparation time and overall impact on hospital resources.

The CHMP opinion is based primarily on data from the phase III SABRINA study. Roche expects a final decision from the European Commission in the coming months.

 

Source: Roche Press Release

Comments are closed

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?

Suggestions?

Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!