Biosimilars

EMA approval for adalimumab biosimilar Imraldi

Biosimilars/News | Posted 30/06/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 June 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Imraldi from Samsung Bioepis.

Trastuzumab biosimilar could reduce breast cancer treatment costs

Biosimilars/Research | Posted 30/06/2017

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Adalimumab and infliximab biosimilars from Sandoz accepted for review by EMA

Biosimilars/News | Posted 30/06/2017

Sandoz, the generics division of Novartis, announced on 31 May 2017 that the regulatory submissions for its proposed adalimumab (GP2017) and infliximab (PF‑06438179) biosimilars had been accepted by the European Medicines Agency (EMA).

Biosimilars of pegaspargase

Biosimilars/General | Posted 30/06/2017

Pegaspargase is a modified enzyme. It is a form of L-asparaginase which has undergone PEGylation. It is used as an anticancer (‘antineoplastic’ or ‘cytotoxic’) chemotherapy drug. It is indicated for the treatment of acute lymphocytic leukaemia (ALL), non-Hodgkin’s lymphoma and for treatment of patients who have had a hypersensitivity reaction to another form of asparaginase.

Biosimilars and sustainability

Biosimilars/Research | Posted 23/06/2017

Competition between brand-name biologicals and biosimilars has the potential to reduce future cancer costs, according to researchers from Italy [1].

EC approval for rituximab biosimilar Rixathon

Biosimilars/News | Posted 23/06/2017

Sandoz, the generics division of Novartis, announced on 19 June 2017 that it had received European Commission (EC) approval for its biosimilar rituximab product Rixathon.

Boehringer Ingelheim’s adalimumab biosimilar ‘equivalent’ to Humira

Biosimilars/Research | Posted 23/06/2017

Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 14 June 2017 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.

UK investigation suggests Merck broke competition law

Biosimilars/General | Posted 23/06/2017

A provisional statement from the UK Competitions and Markets Authority (CMA) says that Merck Sharp & Dohme (MSD) ran an anticompetitive discount scheme for anti-inflammatory drug Remicade (infliximab).

Biosimilar infliximab safe and effective in IBD

Biosimilars/Research | Posted 16/06/2017

A systematic review and meta-analysis of Celltrion/Hospira’s infliximab biosimilar, Remsima/Inflectra found it to be safe and effective in the treatment of inflammatory bowel diseases (IBD) [1].

Recommendations to enhance transparency of biosimilar labels

Biosimilars/General | Posted 16/06/2017

On 6 June 2017, the European Association for Bioindustries (EuropaBio) announced that it had ‘developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars that would result in an enhanced level of transparency in the label’.

FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar

Biosimilars/News | Posted 16/06/2017

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa).

Celltrion making progress with biosimilars in China and Japan

Biosimilars/News | Posted 16/06/2017

South Korean biotechnology company Celltrion has announced advances in its biosimilar rituximab and trastuzumab programmes in China and Japan.

FDA advisory committee to review bevacizumab and trastuzumab biosimilars

Biosimilars/News | Posted 09/06/2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) announced in a Federal Register Notice on 7 June 2017 that it would be reviewing bevacizumab and trastuzumab biosimilars at its next meeting.

Infliximab biosimilar coming closer to interchangeability

Biosimilars/Research | Posted 09/06/2017

Three studies presented at the Digestive Disease Week (DDW) 2017 have shown no significant differences in efficacy or safety endpoint. Two of the studies also specifically tested outcomes in patients switching from the originator infliximab product, Remicade, to the biosimilar version.

Predictive modelling of CIN prophylaxis with biosimilar filgrastim

Biosimilars/Research | Posted 09/06/2017

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

Biosimilars/News | Posted 02/06/2017

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

Biosimilars/Research | Posted 02/06/2017

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

Biosimilars/Research | Posted 02/06/2017

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

Biosimilars/News | Posted 26/05/2017

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

Biosimilars/Research | Posted 26/05/2017

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.