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Positive results for infliximab and trastuzumab biosimilars

Celltrion Healthcare (Celltrion) and Samsung Bioepis have both announced positive results for their infliximab and trastuzumab biosimilars, respectively.

Biosimilarity testing using very low doses of rituximab

Rituximab is a chimeric, monoclonal antibody directed against CD20 expressed on B lymphocytes [1]. Currently approved indications for use are non-Hodgkin lymphomas, chronic lymphatic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic angiitis [2]. However, rituximab is frequently used ‘off label’ for the treatment of numerous antibody-dependent autoimmune diseases [3].

Scientific rationale for extrapolation of cancer indications

Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition. Once biosimilarity has been proven, biosimilars can also be approved for one or more additional indications held by the reference product, without the need for clinical data in those indications. Author Michinori Ogura from the Tokai Central Hospital, Gifu, Japan and colleagues from France and South Korea investigated the scientific rationale for extrapolation using the rituximab biosimilar CT-P10 as an example [1].

Biosimilar insulins have same efficacy and safety as reference biologicals

Researchers from the US have found that biosimilar insulins have comparable safety and clinical efficacy as their reference biologicals [1].

Savings with use of biosimilar trastuzumab for breast cancer patients in Croatia

Breast cancer is worldwide the most common cancer in women. In 2012 alone, there were approximately 464,000 new cases and 131,000 deaths from breast cancer in Europe. In Croatia, breast cancer was the fourth leading cause of death among women and ninth in both sexes in 2016.

Biosimilars and the role of regulatory authorities

According to authors Hye-Na Kang and Ivana Knezevic, from the World Health Organization (WHO), market access to biosimilars can be restricted by several factors [1]: 
(i)   manufacturing processes may be expensive and complex
(ii)  patents on the manufacturing processes of the original product may not have expired
(iii) biosimilar manufacturers may have limited access to data on the original product
(iv)  appropriate regulatory frameworks may not be in place
(v)   government policies on switching to biosimilars, pricing and reimbursement may be lacking.

Life cycle and regulatory evaluation of biosimilars

The life cycle of a biosimilar, like any biological, starts with research and development, then manufacturing, and is followed by regulatory evaluation of quality, safety and efficacy for both licensing and post-licensing oversight. Once licensed, a biosimilar is an individual product and post-licensing evaluation should be carried out like any other biological. The only difference for a biosimilar is that regulatory approval relies on the safety and efficacy data and knowledge gained during the development and licensing of an originator, or reference product.

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].

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].