UCB receives EMA approval for pre-filled pen using Bespak Technology
First disposable autoinjector for a biologic with Bespak technology to be approved by CHMP
The first disposable autoinjector for a biologic from UCB that incorporates Bespak's drug delivery technology has been approved by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
The underlying Bespak technology enables the delivery of highly viscous biotherapeutics in a safe, easy-to-use, and convenient manner to patients, the firm said.
This represents the first application of Bespak’s autoinjector technology in the fast-growing area of biologics.
Consort Medical, of which Bespak is a subsidiary, noted the announcement from UCB that the CHMP has recommended the use of the CIMZIA AutoClicks Prefilled Pen in all approved indications.
The positive opinion was based on validated data and risk benefit analysis for the AutoClicks Pen, the firm said.
This follows the approval, launch and commercialisation of INJ300 for Dr. Reddy's Sumatriptan autoinjector in 2014.
Jon Glenn, Chief Executive Officer of Consort Medical, said: 'This is another important milestone for the Bespak injectable franchise with the approval of our first product into the high value and high growth biologics market.'