Phase XS is a unique analytical platform, which helps you to plan your strategy for biosimilar and biologics development. It is a proprietary tool of Coherent Market Insights (CMI) that aims to provide meticulous details of clinical trials (Phase 3 and Phase 4) conducted in the U.S. along with the analytical insights from the team of CMI consultants and verified by industry experts.
The U.S. FDA accelerated approvals of biosimilars from 2016. It approved five new biosimilars in 2017 as against one in 2015. Around US$ 46 Bn worth of biologics are expected to go off-patent by 2022. Therefore, it is of critical importance to analyze your competition and decide your market entry before it’s too late. Furthermore, the U.S. FDA works in collaboration with sponsors to evaluate and suggest for any flexibility in clinical trial design. Moreover, biosimilars need to prove clinical safety and efficacy in head-to-head comparative studies with the reference product. PHASE-XS encompass information about clinical trial design for phase 3 biologics and biosimilars to support your clinical trial planning.
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