Biosimilars
Advances in ranibizumab and teriparatide biosimilars
Positive results have been reported from a ranibizumab biosimilar and a teriparatide biosimilar has entered phase III trials.
Biosimilars of certolizumab pegol
Certolizumab pegol is a monoclonal antibody directed against tumour necrosis factor-alfa (TNF-α). More precisely, it is a PEGylated Fab’ fragment of a humanized TNF inhibitor monoclonal antibody. It is indicated for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Harmonization of requirements for NBCDs across regions
Efforts are being undertaken to continuously develop and harmonize the regulatory requirements for complex medicinal products across regions. Taking this into account, authors Ehmann and Pita believe the European Union (EU) network is ready for non-biological complex drugs (NBCDs) [1].
US pharmacists’ views on the naming and labelling of biologicals
The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey determining the opinions of US pharmacists about the naming and labelling of biosimilars [1].
Trastuzumab biosimilar submitted for approval in Japan
Japan-based Nippon Kayaku announced on 11 April 2017 that it had submitted an application for its trastuzumab biosimilar, CT-P6, to the Ministry of Health, Labour and Welfare (MHLW) in Japan.
Italian study compares epoetin biosimilars and originator biologicals
Recently, extensive discussion on the opportunity offered by biosimilars for the sustainability of the National Health Services has taken place in academic and regulatory contexts. The use of biosimilars continues to be limited, and the scepticism of prescribers and patients seem to be linked to the uncertainty of the risk-benefit profile of biosimilars. In the case of epoetins, used in the management of anaemia in the nephrology and oncology settings, the results of a recent study showed no difference between biosimilars and originators on relevant effectiveness and safety outcomes [1].
Increasing access to biosimilars and generics in Europe
On 2 March 2017, the European Parliament voted on a resolution to strike a better balance between European Union (EU) countries’ public health interests and those of the pharmaceutical industry.
Basal analogue insulin ‘copy biological’ launched in Indonesia
Indonesian generics maker Kalbe Pharma (Kalbe) announced on 25 March 2017 the launch of a basal analogue insulin ‘copy biological’ in Indonesia.
Filgrastim follow-on biological has similar efficacy and safety in breast cancer patients
A study comparing two filgrastim formulations for controlling chemotherapy-induced neutropenia has reported similar efficacy, safety and non-inferiority of the biosimilar [1].
Amgen at the centre of biosimilars disputes
The disputes involve a biosimilar of Amgen’s biosimilar of Roche’s Avastin (bevacizumab) and Amgen’s blockbuster Neulasta (pegfilgrastim) being made by Coherus Biosciences.
