Amgen Launches Auto-Injector for Reference Etanercept

In an effort to better address the needs of patients taking reference etanercept (Enbrel), Amgen has launched an ergonomically designed cartridge with a reusable auto-injector in the United States as an additional administration option.

The Auto Touch reusable autoinjector is used with Enbrel Mini single-dose prefilled cartridges (50 mg/mL) that utilize a new drug formulation of etanercept that was associated with substantially, significantly lower mean injection site pain than the current formulation, according to Amgen’s phase 3b multicenter, randomized, double-blind, crossover study in adult patients with either moderate to severe rheumatoid arthritis or psoriatic arthritis. The Arthritis Foundation has awarded the product its Ease of Use Commendation.

Sean A. Harper, MD, executive vice president of research and development at Amgen, said that the company was continually striving to innovate to address the needs of patients using the reference etanercept, to understand the challenges they face in injecting the drug, and to create features that will enhance and improve the patients’ experience. The reusable autoinjector has features designed to improve patients’ ease of use, including an ergonomic handle, a needle designed to stay hidden during injection, a sensor to detect placement on the skin, a speed switch with 3 injection speeds, a progress bar, and a speaker.

Improving the delivery of biologics has become an important concern for reference product sponsors who seek to differentiate their products from oncoming biosimilar competition. Earlier this week, Takeda announced that it has partnered with a medical device manufacturer to develop a needle-free approach to administering biologics that are currently administered via injection. Takeda’s proposed device will work by pressuring a liquid drug into a jet that pierces the skin on contact and deliver the therapy in a digitally-controlled and precise manner that takes into consideration factors such as changes in drug viscosity due to temperature. According to the company, the device has been clinically shown to be less painful than a standard injection, and is preferred by patients.

While reference product sponsors seek a competitive edge with new delivery devices, an improved patient experience is also a concern for biosimilar developers, including Sandoz. Sandoz’s etanercept biosimilar, Erelzi, was approved by the FDA in August 2016 (although the company does not expect to launch its product in the United States until 2018 because of patent litigation). Erelzi is already being marketed in the European Union and in Canada, in both auto-injector and pre-filled syringe delivery devices.