Biosimilars and Regulatory Authorities

Department of Pharmaceutical Sciences P. Pratesi, Università degli Studi di Milano, Milan, Italy.
Nephron Clinical Practice (Impact Factor: 1.4). 01/2011; 117(1):c1-7. DOI: 10.1159/000319640
Source: PubMed


The patent expirations for many biotechnological medicines have prompted the development of copies of biological medicinal products. Unlike generics, biosimilars are similar but not identical to their reference product, because their chemical characteristics are directly related to the manufacturing process which cannot be precisely duplicated. The regulatory policy for biosimilars is complex and in Europe it is regulated mainly by guidelines issued by the European Medicines Agency (EMEA); additional product-class specific guidelines have been developed as in the case of recombinant human erythropoietin (rHuEPO). In 2008, the experience gained with this drug has prompted the development of a new guideline, currently in draft. In this review we critically discuss aspects related to EMEA guidelines, particularly focusing on rHuEPO.

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    • "As opposed to generic drugs, follow-on biologics are not copies of innovator drugs. It is impossible to produce exact copies of biologic medical products because of the size and complex structure of the molecules, and complexity involved in the production process [7]. Every change, even the slightest, of production conditions at any stage can bring about changes in quality, cleanliness and biological characteristics, and thus affect the clinical activity and safety of using the drug. "
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    ABSTRACT: The patent expiration for first-generation biological drugs has prompted the development of a new group of biopharmaceuticals - follow-on biologics. The extent of studies needed in the process of follow-on biologics approval is incomparably greater than in the case of generics but reduced in comparison to innovative biologics. The basis for the approval is to show the similarity sufficient to ensure the same quality, safety and efficacy as the reference medicine. In oncology, the most widely used among so far registered follow-on biologics are biosimilar granulocyte colony-stimulating factors, and in the hitherto clinical practice, there have been no concerns about their effectiveness and safety. It is expected that along with the patent expiry of next biologics, the number of follow-on biologics will increasingly grow, that implies the need to develop and implement specific regulations for this new class of medicine.
    Contemporary Oncology / Wsp√≥lczesna Onkologia 01/2012; 16(6):461-466. DOI:10.5114/wo.2012.32475 · 0.22 Impact Factor
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    ABSTRACT: In the European Union (EU), the regulatory policy for biosimilars has enabled different biosimilar products to be marketed through an abridged application, which allows the applicant to submit a reduced dossier. Nevertheless, some manufacturers of biological products that share some characteristics with copies have opted for a full application; therefore, the number and extent of clinical studies required in these cases is increased. Here, we focus on a comparison of recombinant human erythropoietin medicinal products. We analyse and discuss clinical studies submitted to the European Medicines Agency that relate to available biosimilars and biological medicinal products that are authorised with a full dossier. We also discuss the issues of interchangeability and substitution, given that the EU allows each Member State to set their own substitution policies.
    Drug discovery today 08/2011; 17(1-2):63-70. DOI:10.1016/j.drudis.2011.08.001 · 6.69 Impact Factor
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