Biosimilars
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].
EC approval for adalimumab biosimilar Imraldi
Samsung Bioepis announced on 25 August 2017 that it had received European Commission (EC) approval for its biosimilar adalimumab product Imraldi.
Barriers to the market access of biosimilar monoclonal antibodies
In September 2013, the first biosimilar monoclonal antibody (mAb) was approved by the European Medicines Agency (EMA), i.e. biosimilar infliximab (Inflectra/Remsima). These products entered the European market in 2015, after expiry of patent and other exclusivity rights of the innovator medicine Remicade. With the ever-increasing cost of health care and the economic pressure to reduce or sustain healthcare expenses, biosimilars could be instrumental in reducing cost for medication and increasing patient access to treatment. Although exclusivity rights of multiple mAbs are expired (rituximab in 2013, trastuzumab in 2014), only recently biosimilar mAbs other than infliximab are receiving marketing authorization (rituximab, adalimumab). Furthermore, earlier biosimilars have seen slow uptake in European markets. This may imply that several barriers hinder market access of biosimilar mAbs.
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].
