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Evidence on biosimilar efficacy and safety leads to ASAS/EULAR recommendation

A study of biological disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) found no reason for physicians not to prescribe infliximab biosimilars [1].

Improving efficacy of biologicals without increasing cost

Biologicals targeting antitumour necrosis factor-α, such as Remicade (infliximab) and Humira (adalimumab), have been used for the treatment of chronic inflammatory diseases for many years. The advent of biological therapies raised significant pharmacoeconomic concerns, because the cost of biological treatment is much higher than the cost for conventional treatments, typically Euros 10.000‒20.000 per patient per year. This is an issue discussed by Professor Ann Gils from the Department of Pharmaceutical Sciences, KU Leuven, Belgium [1].

Savings to be made by using etanercept biosimilar in UK

A study of patients taking etanercept to treat rheumatoid arthritis or psoriasis in the UK has shown that there are substantial savings to be made by using the biosimilar [1].

Positive results for infliximab biosimilar in Crohn’s disease

Results of a phase III study of Celltrion’s infliximab biosimilar (Remsima; CT-P13) ‘indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease is comparable to those treated with reference infliximab’.

Candidate trastuzumab biosimilar meets equivalence requirements

Mylan and Biocon reported that their jointly developed, candidate trastuzumab biosimilar (MYL-1401O), had met equivalence requirements. The results of the study were published in the Journal of the American Medical Association (JAMA) in January 2017 [1].

Safe for IBD patients to switch to biosimilar infliximab

A UK study has shown that inflammatory bowel disease (IBD) patients can be safely switched from originator infliximab, Johnson & Johnson’s and Merck’s Remicade, to biosimilar infliximab using a managed-switching programme [1].

Regional management of biosimilars in Germany

Biosimilars offer alternative treatment options and reduce the financial burden on healthcare systems often brought about by more expensive originator drugs. Approved biosimilars of tumour necrosis factor-alpha (TNF-α) inhibitors, such as infliximab or etanercept, are managed differently across Europe. A recent study by Dr Mathias Flume assesses the prescription structure and regional uptake of these biosimilars across Germany, with focus on the Westphalia-Lippe region [1].

Positive results for Pfizer’s adalimumab biosimilar

US pharma giant, Pfizer, reported positive top-line results from a comparative study of their candidate adalimumab biosimilar (PF-06410293). The originator biological, AbbVie’s Humira (adalimumab) had sales of just over US$14 billion in 2015 [1], up 11.7% on the previous year, and retaining its place as the top grossing pharmaceutical product globally.

Positive phase III results for adalimumab biosimilar from Coherus

A phase III study of an adalimumab biosimilar (CHS‑1420) from Coherus has reported that the biosimilar is ‘similar’ to AbbVie’s Humira (adalimumab), according to the company.

Position statement on approval of biosimilars in Latin America

The Fifth Latin American Forum on Biosimilars (FLAB) was held in Brasilia, Brazil in 2015 with the theme of ‘Interchangeability and Automatic Substitution’.  Discussions centred on the approval of CT-P13, an infliximab biosimilar; and RTXM83, a proposed rituximab biosimilar, in both Brazil and Argentina. Following these discussions, Babini et al. [1] published a FLAB position statement on the approval of these monoclonal antibody biosimilars in the context of current regulations in these two Latin American countries.

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