mAbxience | Blog

Biosimilar Use Position Paper Of Brazilian Society Of Clinical Oncology (SBOC)

02/19/2018

The Brazilian Society of Oncology has just published its position paper, which includes the most important points on the approval and use of biosimilar drugs in oncology. Also included are aspects relating to their definition, nomenclature, extrapolation, interchangeability, automatic substitution, safety, efficacy and potential impact on healthcare budgets. The Society is in favour of introducing […]

Biosimilars: Lower cost, greater access

02/01/2018

A biosimilar drug is a biological medicinal product that is developed to be highly similar to an existing biological medicinal product (“reference” or “original”).1 Its development is based on existing scientific knowledge and on an exhaustive comparability exercise with the reference biological drug. It is therefore not necessary to repeat all the clinical studies conducted with […]

What do scientific societies say about biosimilars? Rheumatology scientific societies position papers on biosimilar medicinal products

01/18/2018

The increase in the development, marketing and availability of biological therapies has revolutionized the treatment of certain chronic and serious diseases. In this respect, biosimilar medicinal products increase biological medicinal products’ therapeutic offer by reducing health care costs and improving patient access to this type of treatments. This cost-effectiveness improvement, in some cases, has triggered […]

STATUS OF BIOSIMILARS IN LATIN AMERICA

12/19/2017

Regulation of similar biotherapeutic products in Latin America varies widely among different countries and many of them have yet to introduce guidance for biosimilars, Latin America is moving towards increasing standards of regulation for these products. (1, 2) During the last years ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) in Argentina, ANVISA (Agencia Nacional […]

Biosimilars currently approved in Europe and The United States

12/05/2017

Biological medicinal products are proteins that are obtained from living cells (such as fluids, human or animal tissue, microorganisms, etc.). They work by interacting with the body to produce a therapeutic effect via different mechanisms depending on the medicinal product and its indications. (1) As we have seen in previous posts, a biosimilar, or similar biological […]

Extrapolation of indications on biosimilars

05/08/2017

The extrapolation of indications for a biosimilar consists in the regulatory approval of the biosimilar drug for the treatment of diseases that have not been specifically studied during the development of the same. Said approval is only possible if its biosimilarity has been demonstrated and if the mechanism of action is the same among the different indications pending […]