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.
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    ABSTRACT: Biologicals are distinct from small molecule drugs in that they are larger, more structurally complex agents. While the overall risk is modest, the active protein structure characteristic of biologicals makes them more prone to induce an acute and/or chronic immune response. Biosimilars are a new class of drugs intended to offer comparable safety and efficacy to the reference, off-patent biological. They are not generic alternatives per se and are generally not interchangeable. Given their structural complexity, multifaceted manufacturing process and risk for immunogenicity, unique regulatory pathways are required for biosimilars. In this article, we review the clinical, safety and submission requirements for biosimilars in several major markets. We also highlight issues of ongoing debate amongst key stakeholders and examine some of the commercial challenges faced by developers of biosimilars. As the leader of biosimilars drug approval and product uptake, the EU is highlighted.
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