
Recently researchers at Cambridge Polymer Group in collaboration with OrthogenRx coauthored a paper on biosimilar medical devices and methods for supporting performance similarities in specifically viscosupplementation. In this paper, we compare an existing material cleared for sale in the US, against an ex-US device intended to replicate the performance of the existing material as a “generic device” equivalent to generic drugs. The ability to market generic devices has only recently been made possible through changes in the regulatory mechanisms in the US, and this paper discusses this context and describes analytical methods for comparing the performance of viscosupplementation materials. Read the paper here.