Safe’n’Sound® is on the market in Europe with a newly registered injectable
medication.
The commercial launch of HULIOTM (Adalimumab Biosimilar) was initiated in
selected European markets on October 19,2018.
HulioTM, 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 authorizations with Terumo
proprietary PLAJEXTM pre-filled syringe, in combination with Nemera
1ml Safe’n’Sound add-on safety device.
• http://newsroom.mylan.com/2018-10-19-Mylan-Launches-Hulio-TM-
Biosimilar-Adalimumab-in-Markets-Across-Europe
• https://www.terumo-europe.com/en-emea/news/terumo-announces-
european-launch-of-biosimilar-using-terumo%E2%80%99s-plajex%E2%84%A2-
pre-fillable-syringes
Nemera in figures:
- 4 plants in Europe and the USA
- 2 innovation centers (France /
USA)
- Over 2,100 employees
- 30,000 sq. meters of
manufacturing clean rooms
- 150 engineers and experts working
in our Innovation Centers.
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, over 3 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 customizable platform, compatible with prefilled ISO standard
glass syringes as well as PLAJEXTM COP syringe, for 1ml or 2.25ml.
Not only does Safe’n’Sound® improve users safety and injection, but also 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) .
To find out more, contact us.
Press contact
Manuela Basso
External Communication Manager
Manuela.basso@nemera.net