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Biosimilars: implications for oncologists

In 2015, the US Food and Drug Administration (FDA) approved its first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since then, FDA has approved four additional biosimilar tumour necrosis factor α inhibitors, and in May 2017, the Oncology Drug Advisory Committee voted in favour of approval of an epoetin alfa biosimilar. Three biosimilar monoclonal antibodies (mAbs) have been approved in the US. Although their indications are for chronic inflammatory diseases, according to authors Robert Rifkin and Susan Peck, oncologists should become familiar with these agents, because they may need to administer these drugs for patients who have concurrent chronic inflammatory conditions [1].

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].

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.

Efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501

Adalimumab is the most commonly prescribed biological and is approved for rheumatoid arthritis as well as psoriasis, psoriatic arthritis, along with Crohn’s and ulcerative colitis. Its patent life terminated in 2016 in the US [1]. However, in the US AbbVie has stated that, although the composition of matter patent covering Humira expired in December 2016, non-composition of matter patents covering Humira expire no earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis, delaying the launch of biosimilars until January 2023 [2, 3].

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].

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