Details

Autor(en) / Beteiligte

• Bonini, Sergio, MD
• Bonini, Matteo, MD, PhD

Titel

Biosimilars and drug development in allergic and immunologic diseases

Ist Teil von

• Journal of allergy and clinical immunology, 2017-05, Vol.139 (5), p.1461-1464

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2017

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• [...]in the period 2011-2016, 85 biologics were approved by the US Food and Drug Administration (FDA), and 109 biologics were approved by the European Medicines Agency (EMA), with 14 (12.8%) among these last 109 having single (n = 9) or multiple (n = 5) indications in allergic and immunologic diseases.1,2 This changing attitude in drug development is having effects on health care, the pharmaceutical industry, regulators, and payers.3,4 In fact, the higher costs for the development of biologics and their indications frequently confined to selected small populations have produced a significant increase in total drug expenditure that is often not sustainable for many national health services. Biosimilars cannot be considered generics because they have a high molecular weight and a complex heterogeneous structure, are produced through processes strongly dependent on specific experimental conditions, and are usually immunogenic (Fig 1). [...]the comparison of biosimilars with their reference products is more complex than that required for chemical drugs and implies an accurate comparative assessment of their quality and clinical features, which is known as a “comparability exercise.” The EMA has published several documents to regulate the requirements for approval of biosimilars, including an overarching guideline defining principles, general guidelines on quality and nonclinical and clinical aspects to define safety and efficacy, and guidelines for specific products, such as insulin, somatotropin, granulocyte colony-stimulating factor, epoetin, IFN-α, low-molecular-weight heparins, and mAbs.1 The EMA also provides scientific advice that has been shown to be extremely useful for a correct implementation of the guidelines and a...