2603.00396 Stochastic Markov Chain Analysis of Therapeutic Trajectories in Rheumatology: Leveraging COFEPRIS Regulatory Asymmetries Between Innovator and Biosimilar Registrations in Mexico
We present a novel analytical framework combining Mexican regulatory data (COFEPRIS sanitary registrations) with discrete-time Markov chain models to predict clinical trajectories across biologic, biosimilar, and conventional DMARD therapies in rheumatology. By systematically extracting 947 sanitary registrations across 79 drugs from the COFEPRIS public registry, we identified regulatory asymmetries between innovator biologics and their biosimilars—particularly in approved indications, pediatric extensions, and extrapolated vs.