Sanofi launches Dupixent® pens with SHL Medical’s Molly® autoinjector technology
Image Source: “How to take Dupixent”. DUPIXENT, May 2020.
Updated on: June 20, 2020 12 AM EDT
The US FDA approves the 300 mg single-dose 2.0 mL pen presentation of Dupixent®, which is based on SHL Medical’s Molly® 2.25 autoinjector technology, further supporting the convenience self-administration to patients in the US and EU region.
SHL Medical, a leading solutions provider in the self-injection industry, has announced another commercial launch of its Molly® autoinjector family through Sanofi’s Dupixent® pens. The Dupixent® pens are now available for use by patients in the European region.
The Dupixent® pens, available in 1.0 mL and 2.0 mL autoinjector presentations, are built upon SHL Medical’s Molly® technology. A distinct industrial design is featured in both of Sanofi’s Dupixent® pen offerings, which is enabled by Molly®’s flexible design and customization options. The Molly® technology enables an optimized design for manufacturing and can accommodate varying industrial designs to meet client requests, providing the opportunity for product lifecycle management and differentiation in the market.
Sanofi is a global leader in the research, development, and manufacture of pharmaceutical treatments. Sanofi launched Dupixent® in two autoinjector presentations for the European market in March 2020. The commercial launch of the Dupixent® pens marks many firsts in the patient self-administration of complex biologics.
Dupixent® (dupilumab), a fully human monoclonal antibody, is the first and only systemic treatment for atopic dermatitis and is also indicated for asthma. According to research, atopic dermatitis, more commonly referred to as eczema, affects about one-fifth of all individuals during their lifetime.1,2 The product, first approved as a prefilled syringe, is now available to patients in autoinjector presentations. Developed through SHL Medical’s patient-centered design considerations, the pen formats allow for the convenience of self-administration at the comfort of one’s home.
The Dupixent® pen is also the first regulatory approved autoinjector in the high-volume range (≥ 2.0 mL) based on SHL Medical’s Molly 2.25® autoinjector. With a recent trend in the development and approval of complex biologics, the Molly 2.25® autoinjector enables the development of combination products with varying fill volume and viscosity requirements.
“The cooperation with Sanofi to produce both 1.0- and 2.0-mL autoinjector formats of Dupixent® is a monumental milestone for our Molly® autoinjector technology. It has been 10 years since we launched Molly® and it has been continuously supported through a comprehensive infrastructure that allows manufacturing flexibility for various combination product development requirements,” says Josh Gonzalez, Chief Commercial Officer of SHL Medical.
Further information regarding the use of Dupixent® pens can be found here
- Cully M, “Atopic dermatitis therapy breakthrough on the horizon?”. Nat Rev Drug Discov, 2011, Vol 13(9), p 645.
- Bantz S, Zhu Z, Zheng T, “The atopic march: progression from atopic dermatitis to allergic rhinitis and asthma”. Allergy, Asthma Immunol Res, 2011, Vol 3(2), p 67.
- “How to take Dupixent”. DUPIXENT, May 2020: https://www.dupixentmyway.co.uk/atopicdermatitis/about-dupixent/how-to-take-dupixent