Biosimilars/Research

Comparable efficacy and safety observed in patients switched to biosimilar CT-P10

Biosimilars/Research | Posted 22/09/2017

Rituximab is a monoclonal antibody that targets the CD20 protein that is primarily found on B lymphocytes. Through depletion of CD20-positive B cells in the peripheral blood and bone marrow, rituximab is effective for treating some haematological malignancies and immune-mediated diseases such as rheumatoid arthritis (RA). CT-P10 (Truxima) is a biosimilar of the rituximab reference product. It is the first biosimilar to receive market authorization from the European Medicines Agency and is approved in Europe for all indications for which RTX is licensed [1]. A phase I randomized controlled trial (RCT) in patients with RA demonstrated pharmacokinetic equivalence of CT-P10 and reference rituximab over 24 weeks of treatment [2], and comparable efficacy and safety of these two drugs has recently been demonstrated over an extended treatment duration from the same trial [3]. With biosimilars typically being less expensive than originator biologicals [4], it is of interest to know whether patients treated with an originator biological can be switched to a biosimilar to save healthcare costs and increase access without affecting treatment efficacy or safety. An open-label extension (OLE) study that enrolled patients who had completed the aforementioned phase I RCT has been published [5]. The study has demonstrated comparable efficacy and safety profiles in patients who switched from the reference rituximab to CT-P10 and those maintained on CT-P10 throughout treatment [5].

Positive phase III results for Amgen’s trastuzumab biosimilar

Biosimilars/Research | Posted 15/09/2017

Biotech giant Amgen and partner Allergan announced on 9 September 2017 positive data from a phase III study of their trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab).

Positive phase I results for rituximab biosimilar CT-P10 in patients with rheumatoid arthritis

Biosimilars/Research | Posted 15/09/2017

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

Biosimilars/Research | Posted 08/09/2017

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

Biosimilars/Research | Posted 01/09/2017

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

Biosimilars/Research | Posted 01/09/2017

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

Biosimilars/Research | Posted 25/08/2017

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

Biosimilars/Research | Posted 18/08/2017

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/Research | Posted 18/08/2017

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

Biosimilars/Research | Posted 11/08/2017

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].