Biosimilars/Research
Positive phase I results for rituximab biosimilar CT-P10 in patients with rheumatoid arthritis
Rituximab is an established anti-CD20 monoclonal antibody used for the treatment of some haematological cancers and immune-mediated diseases, such as rheumatoid arthritis (RA). CT-P10 (Truxima) is the first biosimilar of the rituximab reference product and was approved in Europe for all licensed RTX indications in February 2017 [1]. A phase I randomized controlled trial (RCT) of CT-P10 versus reference rituximab in patients with active RA demonstrated that the two drugs had equivalent pharmacokinetics after a single course of treatment and that their efficacy, pharmacodynamics, immunogenicity and safety were comparable up to Week 24 [2]. To allow comparison of CT-P10 versus reference rituximab, patients in the same phase I trial received a second course of treatment and were evaluated for efficacy, safety, pharmacokinetics, pharmacodynamics, and other clinical data for up to 72 weeks. These data demonstrate that the clinical profile of CT-P10 is comparable to reference rituximab in patients with RA over an extended treatment duration [3].
Biological drug evolution: improved awareness and pharmacovigilance required
The safety profile of established biological drugs can alter over time following changes to manufacturing processes. However, healthcare professionals are often unaware of changes and there is a need for improved pharmacovigilance, according to a report published by researchers in Scotland, UK [1].
Rituximab biosimilar CT-P10 could save Europe Euros 90 million in its first year
A recent publication in Advances in Therapy suggests that introducing CT-P10, a biosimilar of the anti-CD20 monoclonal antibody rituximab, would generate significant savings for European healthcare systems [1]. CT-P10 is approved by the European Medicines Agency (EMA) for all indications held by reference rituximab, including rheumatoid arthritis and haematological cancers, such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia. Although the therapeutic benefits of anti-CD20 therapy are well established, the cost of reference rituximab is thought to create barriers to patient access [2]. It is hoped that the introduction of more affordable biosimilars will help address this issue. Gulácsi L et al. therefore quantified the potential budgetary impact of introducing CT-P10 for the treatment of rheumatoid arthritis and CD20-positive cancers in 28 European countries [1].
Biological drug evolution: inadequate short-term clinical trials
The safety profile of established biological drugs can alter over time following changes to manufacturing processes and short-term clinical trials fail to isolate adverse events, according to a report published by researchers in Scotland, UK [1].
Adello Biologics starts phase I trial for pegfilgrastim biosimilar
US-based biosimilars specialist Adello Biologics has started a phase I clinical trial for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).
Biosimilar pegfilgrastim highly similar to Neulasta
Canada-based Apobiologix published analytical results demonstrating the similarity of their pegfilgrastim product to the US reference product, Amgen’s Neulasta (pegfilgrastim) [1].
Real-life data supports efficacy and safety of biosimilar filgrastim
Biosimilars of filgrastim are widely used in the prophylaxis of chemotherapy‐induced (CIN) and febrile neutropenia (FN). However, there are limited observational data on the use of granulocyte colony-stimulating factor (G‐CSF) in non‐Hodgkin’s lymphoma (NHL) and its aggressive subtypes including diffuse large B‐cell lymphoma (DLBCL).
Biosimilar trastuzumab candidate shows ‘similarity’ to Herceptin
Results of a phase III clinical study of Celltrion’s biosimilar trastuzumab candidate CT‑P6 demonstrated the ‘similarity’ of the efficacy and safety compared to the originator biological (Herceptin) in patients with HER2+ breast cancer [1].
US prescribers’ views on the naming and labelling of biologicals
The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey in which they asked 400 US physicians for their views on the labelling of biosimilar medicines, and a separate survey in which they asked another 400 US physicians for their views on the naming of biosimilar medicines [1]. All those surveyed were prescribers of biological medicines. The surveys were carried out in the run up to the release of guidance from the US Food and Drug Administration (FDA) on the non-proprietary naming of biological products.
Real world switching data for etanercept biosimilar Benepali
Real world evidence from a study of etanercept biosimilar Benepali (SB4) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have demonstrated ‘sustained efficacy and safety, and high acceptance and adherence in patients initiating treatment with Benepali (etanercept)’, according to Biogen.
