Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Abstract: The US biosimilar programme has been highly successful with 53 biosimilars approved by the US Food and Drug Administration (FDA) for 17 reference products. As in most advanced nations of Europe, all FDA-approved biosimilars may be substituted […]
Abstract: Undoubtedly the complexity of antibody drug conjugate (ADC) molecules where three components (monoclonal antibody, cytotoxic drug and appropriate linker) are involved poses a challenge for biosimilar development. As with all biomolecule development, both novel and biosimilar, it is important to choose orthogonal analytical techniques to interrogate Quality Attributes, particularly for higher order structure (HOS) […]
Abstract: The US Food and Drug Administration (FDA) outlines its approach to biosimilarity and interchangeability at the 2016 Generic Pharmaceutical Association Biosimilars Council Conference. Topics covered include the FDA definition of biosimilarity, its step-wise approach to the approval process and factors/issues that should be considered when providing scientific justification for extrapolation. Submitted: 22 September 2016; […]
Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7 Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent […]
Abstract: With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies and analytics in establishing and confirming biosimilarity are discussed in this paper. Submitted: 28 July 2015; Revised: 15 August 2015; Accepted: 16 August 2015; Published […]
Author byline as per print journal: Valderilio Feijó Azevedo, MD, PhD; Eduardo Mysler, MD; Alexis Aceituno Álvarez, PharmD, PhD; Juana Hughes, MSc; Francisco Javier Flores-Murrieta, PhD, FCP; Eva Maria Ruiz de Castilla, MS, MAA, PhD 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 […]
Author byline as per print journal: Aijing Zhang, PhD, Associate Professor Jung-Ying Tzeng, Professor Shein-Chung Chow, PhD Abstract: When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus, […]
Abstract: The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes for these complex drugs will ensure that evidence of safety and efficacy is obtained before approval. Biosimilars are high on the health-policy agenda because they […]
Author byline as per print journal: Professor Shein-Chung Chow, PhD, Christine Ju, MSc Abstract: Biological (large molecule) drug products are made via living systems and are complex and variable in nature. As a result, generic forms of biological products, also termed biosimilars in the EU or follow-on biologics by the US Food and Drug Administration, can […]
