Biosimilars
EMA approves adalimumab and pegfilgrastim biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 July 2018 that it had recommended granting marketing authorization for the adalimumab biosimilar Hulio and also for the pegfilgrastim biosimilars Pelgraz and Udenyca.
Alternative mAb purification strategies: a tool to increase global access to biotherapeutics?
The monoclonal antibodies’ (mAbs) market is dominant among therapeutic biologicals. Between 2013 and 2017, it has witnessed the approval of 11 biosimilars and 33 new molecules by the regulatory authorities in the EU and the US [1]. A foreseen increase in demand arising from both the western world and several developing countries requires a productivity increase at the same time that the biopharmaceutical industry is being pressured to reduce the costs of life-saving drugs.
Positive switching data for infliximab and etanercept biosimilars
Sandoz, the generics division of Novartis, announced on 15 June 2018 results of new phase III, long-term and switching data for its infliximab biosimilar Zessly (PF‑06438179) and its etanercept biosimilar Erelzi in rheumatoid arthritis patients.
FDA approves filgrastim biosimilar Nivestym
On 20 July 2018, the US Food and Drug Administration (FDA) approved its second filgrastim biosimilar. The filgrastim biosimilar, Nivestym (filgrastim-aafi), is produced by US pharma giant Pfizer.
Switching from Basalin to Lantus effective in Chinese diabetes patients
Switching from copy biological (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus, according to authors from the Qingdao Endocrine and Diabetes Hospital, China [1].
Safety and immunogenicity of originator and biosimilar trastuzumab
A study carried out by international researchers reported results from the HERiTAge trial of Mylan/Biocon’s biosimilar trastuzumab, Ogivri (trastuzumab‑dkst) [1].
European nurses launch biosimilar switching guide
The European Specialist Nurses Organisations (ESNO) announced on 26 June 2018 the launch of a guide for switching from reference biologicals to biosimilars.
Positive phase III results for Amgen’s infliximab biosimilar
Biotech giant Amgen announced on 27 June 2018 positive data from a phase III study of their infliximab biosimilar (ABP 710) compared to Remicade (infliximab).
Rituximab biosimilar submitted to EMA and Rituxan gains extra indication
Poland-based Mabion announced on 1 June 2018 that its candidate rituximab biosimilar (MabionCD20) had been accepted for regulatory review by the European Medicines Agency (EMA).
Biosimilars: implications for oncologists
In 2015, the US Food and Drug Administration (FDA) approved its first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since then, FDA has approved four additional biosimilar tumour necrosis factor α inhibitors, and in May 2017, the Oncology Drug Advisory Committee voted in favour of approval of an epoetin alfa biosimilar. Three biosimilar monoclonal antibodies (mAbs) have been approved in the US. Although their indications are for chronic inflammatory diseases, according to authors Robert Rifkin and Susan Peck, oncologists should become familiar with these agents, because they may need to administer these drugs for patients who have concurrent chronic inflammatory conditions [1].
