Biosimilars
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].
Biosimilars of insulin lispro
Last update: 26 January 2018
Insulin lispro is a fast acting insulin analogue used to treat people living with Type 1 or Type 2 diabetes. Insulin lispro has one primary advantage over regular insulin for postprandial glucose control. It has a shortened delay of onset, allowing slightly more flexibility than regular insulin, which requires a longer waiting period before starting a meal after injection. Both types should be used in combination with a longer acting insulin for good glycaemic control.
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).
Biocad’s rituximab ‘similar biologic’ recommended for approval in India
Russian biotechnology company Biocad announced on 4 July 2017 that it would ‘soon’ receive marketing approval for its rituximab ‘similar biologic’ in India under the trade name Acellbia.
FDA accepts application for Celltrion/Teva’s rituximab biosimilar
South Korean biotechnology company Celltrion and partner Israeli generics giant Teva Pharmaceuticals (Teva) announced on 29 June 2017 that the regulatory submission for their proposed rituximab biosimilar (CT‑P10) had been accepted by the US Food and Drug Administration (FDA).
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].
Setback in Biocon/Mylan’s biosimilar programme after GMP inspection
Biocon/Mylan’s biosimilar programme has hit a stumbling block after failing an inspection by the French inspecting authority (L’Agence nationale de sécurité du médicament et des produits de santé: ANSM).
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.
