Safe’n’Sound Hulio pre-filled syringe launches in Europe

Published: 24-Sep-2019

Safe’n’Sound, the passive safety device platform, is on the market in Europe with a newly registered injectable medication

The commercial launch of Hulio (Adalimumab Biosimilar) was initiated in selected European markets on 19 October,2018.

Hulio, developed by Fujifilm Kyowa Kirin Biologics Co., Ltd. and marketed in the European Union by Mylan N.V., is approved as a biosimilar for the same indications as the reference product, Humira.

This formulation received market authorisations with Terumo proprietary PLAJEX pre-filled syringe, in combination with Nemera 1ml Safe’n’Sound add-on safety device.

In the parenteral industry, needlestick injuries are a global concern, all the more with the growing trend of self-administration. According to World Health Organization, more than three million exposures to blood occur every year, resulting in health, psychological and cost issues.

To ensure adherence and user well-being, Nemera has developed Safe’n’Sound, a fully passive safety device for prefilled syringes. With an ergonomic and robust design, it helps in preventing needle stick injuries, providing a user-friendly protection for healthcare professionals or patients.

This add-on device has been developed for healthcare professionals, patients with self-administered prescribed medications, or individuals that assist self-injecting patients. Safe’n’Sound is a customisable platform, compatible with prefilled ISO standard glass syringes as well as PLAJEX COP syringe, for 1ml or 2.25ml.

Not only does Safe’n’Sound improve user safety and injection, the device complies with the recommendations of the World Health Organization, US FDA (US Federal Needle stick Prevention Act, 2000) and the EU Medical Device Regulation 2017/745 (MDR).

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