VOLUME 1 - NUMBER 1 - 2021

Biosimilars open up new opportunities in chronic diseases

  • Maria Luisa Brandi
  • Original article, 34-37
  • Full text PDF

  • The World Health Organization defines a biosimilar product as a biotherapeutic that is similar in terms of quality, safety and efficacy to an already licensed reference product available on the market. To ensure similar efficacy and safety, comparability studies for biosimilars should be carried out at quality, preclinical and clinical level. In this article we provide an overview of biosimilars, looking at the definition of the term biosimilar, the regulatory framework and the future prospects for these drugs. As biosimilar drugs will revolutionize the treatment of osteoporosis, this paper aims to evaluate the pros and cons of choosing the teriparatide biosimilar Movymia®, looking at whether it really can be considered clinically equivalent to the original drug. The benefits of biosimilars may include improving patient access and affordability. Off-patent biologics and biosimilars may also create market competition and stimulate incremental innovation by manufacturers.

  • KEY WORDS: Biosimilars, biobetters, biological drugs, teriparatide.