Biosimilars

Biosimilars of abatacept

Biosimilars/General | Posted 02/12/2016

Last update: 28 April 2017

Abatacept is a modified antibody biological drug used to treat autoimmune diseases like rheumatoid arthritis, by interfering with the function of particular cells (T-cells) in the immune system. This action modifies the inflammation and immune activity which cause the symptoms of rheumatoid arthritis.

Mylan and Biocon submit insulin glargine biosimilar to EMA

Biosimilars/News | Posted 02/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 3 November 2016 that the regulatory submission for their proposed insulin glargine biosimilar had been accepted for review by the European Medicines Agency (EMA).

Biosimilars help reduce the costs of cancer care

Biosimilars/Research | Posted 02/12/2016

The costs for cancer drugs have been increasing significantly in countries around the world. With the arrival of new therapies, the future of cancer care is exciting. But how will healthcare systems be able to pay for such innovations? In their commentary, Goldstein and co-authors discuss how biosimilars could help alleviate such challenges [1].

Safety differences in clinical trials for biosimilars

Biosimilars/Research | Posted 25/11/2016

Differences in safety evaluations and findings between clinical trials for biosimilars are highlighted by researchers from the University of Massachusetts, USA and Newcastle University in the UK. This they argue is a reason for clinical trial design for biosimilars to be standardized [1].

FDA accepts application for bevacizumab biosimilar

Biosimilars/News | Posted 25/11/2016

Biotech giant Amgen and its partner Allergan, announced on 15 November 2016 that the regulatory submission for its proposed bevacizumab biosimilar (ABP 215) had been accepted for review by the US Food and Drug Administration (FDA). The companies believe this submission is the first bevacizumab biosimilar application submitted to FDA.

Assessing analytical comparability for G-CSF biosimilars

Biosimilars/Research | Posted 25/11/2016

According to the US Food and Drug Administration (FDA), a biosimilar is a biological product shown to be ‘highly similar to an FDA-approved biological product’, and which ‘has no clinically meaningful differences in terms of safety and effectiveness’. Only minor differences in clinically inactive components are allowable in biosimilars. Biosimilars of approved biologicals at the end of their patent life are expected to cost less but be as safe and effective for licensed clinical uses. To date, FDA has approved four biosimilars [1], while the European Union has approved more than 20 biosimilars [2].

Portuguese dermatologists’ position on the use of biosimilars in psoriasis

Biosimilars/General | Posted 25/11/2016

Biologicals have revolutionized the treatment of psoriasis and psoriatic arthritis. However, they impose a heavy burden on the healthcare system due to their high costs. In 2013, 27% of pharmaceutical sales were for biologicals. In 2015, two of the top five best-selling therapies were tumour necrosis factor-alpha (TNF-α) inhibitors, adalimumab and etanercept. Biosimilars, which may cost 25−30% less than the originator biological, thus represent a significant opportunity for savings to be made by both patients and healthcare systems.

Extrapolation of indications for biosimilar infliximab and etanercept

Biosimilars/Research | Posted 18/11/2016

Biosimilar infliximab (Inflectra/Remsima) was approved in Europe in September 2013 for the same indications as the originator product (Remicade). More recently, biosimilar etanercept (Benepali) was approved in Europe in January 2016 for the same indications as the originator product (Enbrel) [1]. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss the extrapolation of the indications for the biosimilars [2].

EMA approves biosimilars of insulin glargine and teriparatide

Biosimilars/News | Posted 18/11/2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 November 2016 that it had recommended granting of marketing authorization for an insulin glargine biosimilar and two teriparatide biosimilars.

Celltrion submits trastuzumab biosimilar application to EMA

Biosimilars/News | Posted 18/11/2016

South Korean biotechnology company Celltrion has, according to The Korea Herald, submitted another biosimilar application to the European Medicines Agency (EMA).