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

Abstract:

The COVID-19 pandemic has sparked a race for pharmaceutical companies to focus on developing new drugs and vaccines to deal with the disease. It has also led to the reuse of marketed drugs approved for other clinical indications to treat patients suffering from COVID [1]. Biologicals, biotechnology drugs, or bio-pharmaceutical products are large complex biomolecules with a heterogeneous structure, extremely sensitive to process changes and generated by cells or living organisms through recombinant deoxyribonucleic acid (DNA) technology, controlled gene expression, or antibody production. They encompass a wide range of substances, including hormones, vaccines, growth factors, blood products, monoclonal antibodies, and advanced technology products, eg protein–antibody combinations and gene therapy biological products [2]. Biosimilars have been defined as a copy version of an already authorized biological medicinal product with demonstrated similarity in physicochemical characteristics, efficacy, and safety, based on a comprehensive comparability exercise [3]. Unlike smallmolecule generics, biologicals are larger and more complex, and therefore production can be difficult to standardize; even within the same manufacturer it is not possible to copy a biological in a precise manner in the ways that small molecules can be replicated. Thus the term ‘generic biologic’is inappropriate [4].

Año de publicación:

2021

Keywords:

Fuente:

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