Article

Biosimilars and Regulatory Authorities

Department of Pharmaceutical Sciences P. Pratesi, Università degli Studi di Milano, Milan, Italy.
Nephron Clinical Practice (Impact Factor: 1.65). 01/2011; 117(1):c1-7. DOI: 10.1159/000319640
Source: PubMed

ABSTRACT 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.

1 Follower
 · 
113 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defined by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency. We review biosimilars and the current European Union and US regulatory pathways for biosimilars. Furthermore, we propose a checklist of considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion. Included in the checklist are considerations related to the availability of preapproval and postapproval safety and efficacy data; differences in product characteristics and immunogenicity between the biosimilar and reference product; manufacturer-related parameters that can affect a reliable supply of quality products; health-system and patient perspectives on product packaging, labeling, storage, and administration; costs and insurance coverage; patient education; interchangeability and differences in the range of indications; and evaluation of institutions' information technology systems.
    Hospital pharmacy 10/2014; 49(9):813-825. DOI:10.1310/hpj4909-813
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: With the emergence of biosimilars as a new class of biotherapeutic agents, the use of these products in Latin America has become a focus of attention. To aid policymakers and regulatory authorities, a group of experts on biosimilars developed a series of recommendations for the regulation of biosimilars and their implementation in the region. Although most of the Latin American countries have adopted, in general, the WHO recommendations; there are some of them whose regulations diff er from WHO. Unfortunately, the pace at which the region moves toward reaching its potential of having safe and eff ective biosimilars has been slow. Countries in the region must enhance their eff orts to improve pharmacovigilance to include training more regulatory staff , more public and professional awareness on the importance of reporting adverse events and better systems to capture and analyze data. Regulatory authorities should also establish a process whereby the traceability of an adverse event to a biosimilar can be determined. Products previously approved as ‘intended copy’ drugs should be evaluated according to regulations specifi c to biosimilars. It cannot be assumed that a previously approved biopharmaceutical is actually a biosimilar, regardless of current clinical experience. Latin America is no exception to the slower-than-expected pace of developing regulations on biosimilars. The panel’s perspectives on the current status led to six major recommendations in order to enhance the safe use of biosimilars in the region.
    06/2014; 3(3):1. DOI:10.5639/gabij.2014.0303.032
  • [Show abstract] [Hide abstract]
    ABSTRACT: The impending expiration of patent protection for recombinant insulins provides the opportunity to introduce cost-saving copies, named biosimilars, onto the market. Although there is broad experience in the production and characterisation of insulins, the development of copies is still a challenge. In this paper, the main features of insulins and the EU regulatory framework for their biosimilar products are reviewed. The main focus is on rapid-acting insulin analogues (Humalog(®); Novolog(®)/NovoRapid(®); Apidra(®)). Since they differ by one or two amino acids in chain B, production of one biosimilar for all three drug products is not feasible. However, from post-marketing-collected clinical data, rapid-acting insulin analogues seem to have similar therapeutic efficacy. It is reasonable to suppose that, for prescription to treatment-naïve patients, the cheaper biosimilar would be the preferred choice of physicians, either spontaneously or induced by health insurance. Therefore, its introduction will affect the market share of all the other rapid-acting insulin analogues.
    BioDrugs 03/2015; 29(2). DOI:10.1007/s40259-015-0121-x · 2.12 Impact Factor