Biosimilars
Predictive modelling of CIN prophylaxis with biosimilar filgrastim
Granulocyte colony-stimulating factors (G-CSF) stimulate white blood cell production and as such are indicated in the prophylaxis of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Risk models of CIN/FN to date focus on predictors measured at the start of chemotherapy. Aapro and colleagues used a dynamic approach of CIN/FN risk modelling at the start of each cycle.
EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics
Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics announced on 22 May 2017 that its application for approval for its proposed adalimumab biosimilar (FKB327) had been accepted by the European Medicines Agency (EMA).
How the FDA regulates biosimilars
The advent of recombinant DNA-technology ushered in the development of novel therapeutic protein products that have become mainstays of treatment regimens against cancer, inflammatory disorders and other serious diseases and conditions. Recombinant therapeutic proteins are typically large, complex molecules that are produced in cultured cells and manufactured using complex, multistep purification processes. Despite some of these products being ‘off-patent’ for years, they remain among the most expensive pharmaceuticals in the US and the world. One approach that governments across the globe have taken to reduce healthcare costs is to give regulatory authorities the ability to approve biologicals using an abbreviated licensing pathway that includes achieving the rigorous standard of demonstrating ‘biosimilarity’ with an already approved biological product.
Positive phase III results for Sandoz’s adalimumab biosimilar
A phase III study of a proposed adalimumab biosimilar (GP2017) from Sandoz has met its primary endpoint ‘demonstrating equivalent efficacy’ to AbbVie’s Humira (adalimumab).
EMA approval for insulin and rituximab biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it had recommended granting marketing authorization for Insulin lispro Sanofi and for the rituximab biosimilars Blitzima, Ritemvia and Tuxella.
Biosimilars in the treatment of inflammatory bowel disease
Inflammatory bowel disease (IBD) is mainly characterized by two chronic, relapsing, immune-mediated inflammatory diseases of the gastrointestinal tract: Crohn’s disease and ulcerative colitis. Approximately 1.4 million Americans are affected by IBD and afflicted with recurrent symptoms of bloody diarrhoea, abdominal pain, bowel obstruction, and other co-morbid conditions. The introduction of biologicals, highly complex molecules manufactured from living organisms, was a revolutionary advance in treating threatening and life-debilitating inflammatory diseases. Biologicals, particularly those that target tumour necrosis factor (TNF) signalling, have provided IBD patients with an efficacious method of treatment with regards to symptom management and mucosal healing. Nevertheless, the rising prevalence of IBD worldwide and the ever-increasing cost burden of biologicals in the healthcare industry is alarming for insurance companies, clinicians and patients.
EMA guidance for NBCDs and products approved
The European Medicines Agency (EMA) has published reflection papers on nanomedicines and their follow-on versions [1]. It has also published a wide range of other guidance, which outlines the technical requirements to demonstrate the quality, safety and efficacy of medicines that may also be applicable to non-biological complex drugs (NBCDs), according to authors Ehmann and Pita [2].
Danish infliximab switching study shows no difference
A study published by researchers from Denmark has found that switching from originator to biosimilar infliximab has ‘no negative impact on disease activity’ [1].
Post-marketing experience with IBD biosimilars
The introduction of anti-tumour necrosis factor-alpha (TNF-α) monoclonal antibodies (mAbs), about two decades ago, has revolutionized the management of inflammatory bowel disease (IBD). However, they are also expensive and their cost can lead to restricted access for many patients.
Biosimilars applications under review by EMA – April 2017
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
