Our objective was to evaluate the immunogenicity of branded and biosimilar infliximab by detecting changes in T-helper-9 (Th9) percentages induced by an in vitro stimulation test. METHODS Peripheral blood mononuclear cells collected from 55 consecutive rheumatoid arthritis (RA) outpatients (15 drug free, 20 successfully treated with branded infliximab, 20 branded infliximab inadequate respond...

OBJECTIVES The aim of this study was to determine whether antibodies to infliximab (IFX) in Remicade-treated patients cross-react with the biosimilar CT-P13. METHODS 250 consecutive patients with rheumatic diseases under Remicade and 77 controls were retrospectively selected for the study. Anti-IFX antibodies at drug through levels were measured in parallel with three different bridging ELISA...

Biologics such as rituximab are an important component of oncology treatment strategies, although access to such therapies is challenging in countries with limited resources. This study examined access to rituximab and identified potential barriers to its use in the United States, Mexico, Turkey, Russia, and Brazil. The study also examined whether availability of a biosimilar to rituximab would...

AIM The purpose of this study was to assess the prescription of epoetins and consumption of health care resources (in terms of drug treatments) in naïve patients with hematological malignancies in a real-world setting; in particular, we compared the results between reference product and biosimilar products. METHODS An observational retrospective study based on administrative and laboratory da...

FDA pleases no one with final guidance on biological and biosimilar naming.

Zarxio (filgrastim-sndz), a biosimilar for the treatment of severe chronic neutropenia.

The European Medicines Evaluation Agency (EMEA) has developed guidelines to ensure similarity, ‘in terms of quality, safety and efficacy’, between similar biological medicinal products (biosimilars) in comparison to the originators (http://www.emea.eu.int). The quality and safety of biosimilar recombinant human erythropoietins (rhEPOs) has been previously discussed [1–3]. The present comment fo...

Patent protection and FDA exclusivities are the two principal forms of protection available to companies that develop therapeutic monoclonal antibodies. Propo-sed changes to both forms of protection are currently being debated in the United States Congress. Specifically, Congress is presently debating both biosimilar and patent reform legislations. Although no bill has yet passed, it is expecte...

[1]. In order to evaluate biosimilarity between an innovator and biosimilar product, the FDA recommended a stepwise, riskbased totality of evidence approach. In addition to extensive structural and functional characterization, effort must also be made on preclinical development in terms of animal toxicity studies and the assessment of pharmacokinetics (PK) and immunogenicity. Although there are...

Dear editor I write in response to an article published in January 2016 regarding Colombia’s 2014 regulation governing registration of biosimilar biological products (1). In my view, the article seriously misstates international norms regarding approval of biosimilars and creates a misimpression that the new Colombian regime is consistent with the approach taken in Europe and the United States....