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Regulating biosimilars throughout their life cycle

A resolution to increase access to life-saving biologicals was passed in May 2014 at the Sixty-seventh World Health Assembly of the World Health Organization (WHO) [1]. However, there still exist barriers to market access for biosimilars. Authors Drs Hye-Na Kang and Ivana Knezevic, from WHO, discuss the factors that give rise to these barriers and explain the importance of regulatory oversight throughout the product life-cycle of biosimilars [2].

Interchangeability between infliximab biosimilars with respect to immunogenicity

In their editorial, Katsanos and colleagues [1] discuss a study carried out by Italian and Spanish researchers on the immunogenicity of infliximab biosimilars that finds that there is full interchangeability between infliximab biosimilars with respect to immunogenicity [2].

Biosimilars in Europe

The European Medicines Agency (EMA) has pioneered the regulatory aspects of biosimilars since the first approval of a biosimilar in 2006. With the last authorization of bevacizumab in January 2018, 44 biosimilar products have been reviewed by the Committee for Medicinal Products for Human Use (CHMP) of EMA, 41 of them having been granted a marketing authorization [1].

Utilization data and cost-effectiveness of infliximab biosimilar

Studies of Celltrion/Hospira’s infliximab biosimilar (CT‑P13, Remsima/Inflectra) carried out in Canada and Germany have shown that, although there are large savings to be made, there are ‘significant differences in real-world utilization patterns’ of patients prescribed originator infliximab compared to those prescribed biosimilar infliximab (CT‑P13) [1, 2].

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

Factors that Professor Frank believes may be affecting uptake include naming and interchangeability guidance, insurance payment arrangements and secrecy about manufacturing processes [1]. In this article, secrecy about manufacturing processes is discussed.

Safety of biosimilar infliximab in pregnant women with IBD

Introduction of the first biosimilar infliximab (CT‑P13, Remsima/Inflectra) for the treatment of inflammatory bowel diseases (IBDs) was aimed to reduce the healthcare cost burden and to increase the number of treated individuals with similar treatment results. Shortly after CT‑P13 has been authorized for usage in clinical practice, many concerns arose due to the fact that the principle of extrapolation of limited clinical results had been applied to the biosimilar, which led to approval of the biosimilar in all the indications of the originator biological (Remicade). However, these concerns have proved to be unfounded, as subsequent studies have confirmed the similar efficacy, safety and immunogenicity of CT‑P13 and Remicade in the general IBD population [1].

Insurance payment arrangements are an obstacle to biosimilars use in the US

The slow development of the market competition for biosimilars in the US may be caused by several factors, according to Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA [1]. In this article, insurance payment arrangements for biologicals and biosimilars are discussed.

Biosimilars in rheumatology: the current state of play

Biological disease modifying anti-rheumatic drugs (bDMARDs) have revolutionized the management of rheumatoid arthritis (RA) and other inflammatory diseases. Over two decades, their use has risen exponentially but their significant cost has contributed to increasing healthcare expenditure in many countries. Biosimilar development is an opportunity to lower drug expenses and optimize use. This review detailed the current state of biosimilars in rheumatology, including their development, trial data, economic impact and logistical considerations [1].

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.