Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

At the beginning of the COVID-19 pandemic, Ecuador was unprepared for the overwhelming number of COVID-19 cases. As the general population started to see the eff ects of the pandemic, unproven treatments and medications were sought by the population to try to ameliorate the impact of the pandemic. The growing demand for a cure, the fear of dying from COVID-19, and the lack of therapeutic rigour, pushed a signifi cant number of people to seek help outside the traditional healthcare system. Doctors, pharmacists, and patients started prescribing or selfmedicating pharmacological products that were later shown to be ineff ective, toxic or even contraindicated. In Ecuador, most people who developed the severe acute respiratory syndrome associated with infection by the coronavirus 2 (SARS-CoV-2) virus, which causes COVID-19, used antibiotics (azithromycin), antiparasitic medications (hydroxychloroquine or ivermectin), dangerous chemical products (chlorine dioxide) and in some cases, biological medicines, to try to cure or protect themselves from COVID-19. The growing demand for therapies that were unavailable, as well as the rise in misinformation, created the perfect scenario for the misuse of medicines and enabled the appearance of a rampant black market of unregistered biological products. In this manuscript, we describe the Ecuadorian experience in relation to the off -label use of biological and biosimilar products during the COVID-19 pandemic, the role of the pharmaceutical black market, and the lack of national regulations to avoid dangerous practices. To the best of our knowledge this is the fi rst report that has aimed to describe the unapproved and even illegal sale and use of biologicals, biosimilars and related products, with or without approved therapeutic indications in the treatment of COVID-19.