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Approval of biosimilars in rheumatology

Biosimilars are approved following a regulatory pathway different to that of generics, as they are not molecularly identical to their reference products. Currently, only one biosimilar is approved by the European Medicines Agency (EMA) for the treatment of rheumatological diseases: an infliximab biosimilar, which is commercialized as Remsima/Inflectra [1]. With this approval in mind, author Gilberto Castañeda-Hernández and co-authors discuss what rheumatologists should know about biosimilars [2].

Real-life results for Inflectra compared to Remicade

Results of a post-marketing clinical study of infliximab biosimilar Inflectra demonstrated equivalent effectiveness compared to the originator biological (Remicade) in patients with rheumatoid arthritis and ankylosing spondylitis when switched from Remicade [1].

Biosimilars in the US

The US Food and Drug Administration (FDA) approved the country’s first biosimilar Zarxio (filgrastim-sndz) on 6 March 2015 [1]. But how will biosimilars be classified in the future and how will savings for biosimilars be realized in the US? These are questions Sarpatwari and co-authors sought to answer [2].

Remsima shows comparable safety and efficacy in IBD patients

South Korean biotechnology company Celltrion presented results of clinical experience for its infliximab biosimilar Remsima (CT-P13) at Digestive Diseases Week (DDW) 2015, which was held in Washington DC, USA, on 17–19 May 2015.

Inflectra shows comparable results in IBD patients

US-based generics maker Hospira presented preliminary results from its Hungarian National Registry study for its infliximab biosimilar Inflectra at the European Crohn’s and Colitis Organisation Inflammatory Bowel Diseases (ECCO-ibd) conference, which was held in Barcelona, Spain on 18–21 February 2015.

Cost of filgrastim biosimilars compared to originator filgrastim

Italian researchers have completed a retrospective cost analysis comparing the use of filgrastim biosimilars with the originator granulocyte colony-stimulating factor (G-CSF). Their retrospective, single institution study of 56 lymphoma and myeloma patients concluded that treatment with the biosimilars Tevagrastim and Zarzio was associated with cost reductions of 56% and 86%, respectively.

Biosimilars for the treatment of Crohn’s disease

The introduction of targeted biological therapies has improved the treatment of immune inflammatory arthritis and other autoimmune diseases, in particular, Crohn’s disease (CD). The monoclonal antibodies infliximab and adalimumab have shown beneficial effects in patients with CD and high disease activity. The forthcoming introduction of biosimilars is expected to improve access to these expensive medications with an expected reduction in price ranging from 20 to 40 per cent of the present cost.

Clinical trials for etanercept biosimilars

Researchers from the Charité – Universitätsmedizin Berlin, Germany, carried out a systematic review into clinical trials for etanercept biosimilars as part of their investigation into biosimilars for the treatment of psoriasis [1].

Clinical trials for infliximab biosimilars

A systematic review into clinical trials for infliximab biosimilars was carried out as part of an investigation into biosimilars for the treatment of psoriasis by researchers from the Charité – Universitätsmedizin Berlin, Germany [1].

Incomplete processing in recombinant streptokinase

A study investigating the impact of incomplete processing on streptokinase activity has found that ‘similar biologics’ or different batches of the biological may have different potencies, depending on the degree of amino-terminal methionine processing and on the pharmacopoeial assay method used, affecting the dosage patients receive [1].

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