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Interchangeability is an obstacle to the use of biosimilars in the US

According to Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA, there are several factors that may account for the slow development of the market for biosimilars in the US [1]. In this article, the issue of interchangeability of biosimilars is discussed.

Phase I study of biosimilar trastuzumab demonstrates equivalent pharmacokinetics to reference product

Trastuzumab, a recombinant humanized monoclonal antibody, acts against the tyrosine kinase human epidermal growth factor receptor 2 (HER2), which is overexpressed in up to 30% of breast cancers and gastric cancers and has been linked to poor prognosis. In the age of targeted anticancer therapy, trastuzumab is a key treatment for patients with HER2-positive (HER2+) tumours and is recommended by a number of clinical guidelines. However, the use of ‘originator’ (or reference) biologicals, such as trastuzumab, is associated with high treatment costs; an issue set to be exacerbated by an ageing population. The improved cost-effectiveness potentially provided by a biosimilar may increase patient access to treatment.

Afucosylated biosimilars: the path to matching interrelated critical quality attributes

Advances in analytical characterization and increased understanding of drug mechanisms of action have resulted in the ability to raise the quality and safety of biosimilars by introducing critical quality attributes (CQA), which must be preserved during the manufacturing process. However, to realize these benefits, biosimilars manufacturers must develop the means to ensure these CQAs are met. For afucosylated IgG1s that rely on afucosylation content for efficacy, this has been challenging, since precisely matching both afucosylation content and biological activity has proven to be extremely difficult. In a recent paper, Chung and Zhan [1] elaborate on the underlying basis of these difficulties and highlight the work of several groups that has opened a path to directly addressing this problem.

Naming is an obstacle to the use of biosimilars in the US

Factors that may account for the slow development of the market for biosimilars in the US are discussed by Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA [1]. In this article, the factor of biosimilars naming is discussed.

Obstacles to the use of biosimilars in the US

Professor Richard G Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA, discusses factors that may account for the slow development of competition in the market for biosimilars in the US [1].

Strategies for development and validation of neutralizing antibody assays supporting biosimilars

A biosimilar is a biological product with equivalent safety, purity and potency as an originator reference therapeutic. As such, US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines have stepwise recommendations to demonstrate biosimilarity, which include immunogenicity assessment.

Biosimilar policies in Europe

Across European countries, differences exist in biosimilar policies, e.g. pricing and reimbursement procedures, levels of education, characteristics of covered population and incentivization of stakeholders, leading to variations in uptake of biosimilars and divergences in savings from biosimilars use. Experiences from different European countries with biosimilar policies may offer useful insights into current and future uptake of biosimilars.

Etanercept biosimilar SB4 less immunogenic than Enbrel

A research letter published in the British Journal of Dermatology suggests that the biosimilar etanercept SB4 is less immunogenic than the originator product, Amgen/Pfizer’s Enbrel (etanercept) [1].

Spanish gastroenterologists update biosimilar position statement

The Spanish Society of Gastroenterology (Sociedad Española de Patología Digestiva,SEPD) has updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD) [1]. The changes in the society’s position reflect the increasing body of evidence supporting the safety and efficacy of biosimilars.

Government policies to maximize social benefit of biosimilars in countries with restricted access to biologicals

The potential value of biosimilars is dependent on patient access to originator biologicals in a given country. If the originator biological is reimbursed without any volume and access restrictions, the main objective of using biosimilars is to generate savings in health expenditures without compromising health outcomes. This disinvestment scenario is mainly applicable for higher income countries. If the original biological product is reimbursed with volume and access restrictions, the main objective of biosimilars is to treat more patients from the same healthcare budget, and hence generate more health gain. This special investment scenario is applicable for lower income European Union (EU) Member States and other middle-income countries. If the originator biological is not reimbursed at all, more affordable biosimilars may create an opportunity for public reimbursement, however, incremental budget is needed to generate more health gain. This investment scenario is applicable for low-income countries [1].

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