A new market reference added to Safe’n’Sound®, our passive safety device platform Safe’n’Sound® 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 October 19,2018. 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 authorizations with Terumo proprietary PLAJEX™ pre-filled syringe, in combination with Nemera 1ml Safe’n’Sound add-on safety device. “There is no limit to Nemera’s ambition to serve patients. We already market devices in over 40 countries for millions of users. We’ll keep investing in new products and in state-of-the-art manufacturing equipment, to help even more patients with high quality devices all over the world.” Marc Haemel, CEO.
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 selfinjecting patients. Safe’n’Sound® is a customizable 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 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) .
Nemera is one of the world leaders in the design, development and manufacturing of drug delivery solutions. Its expertise covers all five modes of delivery: Nasal/Buccal/Auricular (spray pumps, actuators, valves, etc.), Ophthalmic (preservative-free droppers), Pulmonary (pMDI, MDI’s, DPI’s), Dermal /Transdermal (airless & atmospheric dispensers), and Parenteral (autoinjectors, pens, and safety devices). Nemera provides solutions for the pharmaceutical industry, including standard innovative products, the development of proprietary devices and contract manufacturing.