EU approves second indication for subcutaneous form of Roche's rituximab

By Dan Stanton contact

- Last updated on GMT

Rituximab binding to cell-surface marker CD20, found on developing B cells. Image c/o Roche
Rituximab binding to cell-surface marker CD20, found on developing B cells. Image c/o Roche
Roche’s subcutaneous formulation of MabThera is about reducing the treatment burden for patients and not protecting it from impending biosimilar competition, the firm says.

Swiss pharma giant Roche announced yesterday that the European Commission (EC) approved a subcutaneous (SC) version of its blockbuster biologic MabThera (rituximab) for people with chronic lymphocytic leukaemia, the second indication approved for the formulation.

The fixed-dose formulation “offers the delivery of MabThera under the skin instead of via intravenous (IV) infusion,” ​Roche spokesperson Dr. Ulrike Engels-Lange told this publication.

“As MabThera SC can be given under the skin, it cuts delivery to approximately 7 minutes compared with 2.5 hours for the intravenous formulation, without compromising MabThera’s proven efficacy and safety.”

Biosimilar competition

MabThera – marketed under the brand name Rituxan and sold by Biogen in the US - has been a major product for Roche since its approval in the EU in 1998.

Last year, global Mabthera/Rituxan sales stood at over CHF 7bn ($7.1bn) but the product has lost its exclusivity in Europe and biosimilar makers Celltrion​ and Sandoz​ have had their rituximab products accepted for review by the European Medicines Agency.

Pharma companies facing patent expirations often look to extend the lives of blockbusters by developing new formulations​ or device-combinations​, but Engels-Lange would not comment on whether Roche was pursuing such a strategy to protect its biologics portfolio.

Instead she told us the subcutaneous route of administration had been developed to bring clinical benefits to patients. “MabThera SC is reducing the treatment burden for patients, [and] reducing the time and resources required at the treatment facility to treat patients with MabThera.”

As to the looming copycat versions of MabThera, she said “it is too early to speculate on the potential impact of biosimilars.”

Related topics: Bio Developments, Biosimilars

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