Biosimilars

US drug contracting system is ‘rigged’ against biosimilars

Biosimilars/General | Posted 16/03/2018

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has said that the drug contracting system in the US is ‘rigged’ against biosimilars. His remarks came during a speech he made on 7 March 2018 at the America’s Health Insurance Plans National Health Policy Conference in Washington DC.

ASCO issues position statement on biosimilars in oncology

Biosimilars/General | Posted 09/03/2018

The American Society of Clinical Oncology (ASCO) has issued a position statement on biosimilars in oncology. The statement reflects the society’s views on issues such as naming, labelling, safety and efficacy, interchangeability, switching and substitution of biosimilars, as well as on the value of biosimilars and prescriber and patient education [1].

Trastuzumab biosimilar launched in South Korea

Biosimilars/News | Posted 09/03/2018

South Korean pharmaceutical company Daewoong Pharmaceutical announced on 5 March 2018 that it had launched trastuzumab biosimilar Samfenet, developed by Samsung Bioepis, in South Korea.

Use and cost of biologicals for cancer treatment in Southern Italy

Biosimilars/Research | Posted 09/03/2018

Oncological-targeted therapies, both biological and non-biological, represent a significant clinical and economic burden in routine care and have a major impact on the sustainability of National Health Services. With this in mind, a study by Lucchesi et al. investigated the use and costs of these targeted therapies for cancer treatment in the general population of Southern Italy during the period 2010−2014 [1].

Cadila and Kalbe advancing biosimilar ambitions

Biosimilars/General | Posted 09/03/2018

Indian generics maker Cadila Healthcare (Cadila) and Indonesia-based Kalbe Farma (Kalbe) are both making advances into the biosimilars field.

Kissei/JCR’s darbepoetin alfa biosimilar shows equivalent safety and efficacy

Biosimilars/Research | Posted 02/03/2018

Japan-based collaborators Kissei Pharmaceutical (Kissei) and JCR Pharmaceuticals (JCR) announced on 17 January 2018 positive results for the phase III study of their candidate darbepoetin alfa biosimilar, JR‑131.

EC approval for trastuzumab biosimilar Herzuma

Biosimilars/News | Posted 02/03/2018

South Korean biotechnology company Celltrion announced on 14 February 2018 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Herzuma (CT‑P6).

Pharmacy-mediated substitution: the global policy landscape

Biosimilars/Research | Posted 02/03/2018

There is a complex global regulatory landscape when it comes to biosimilars. In particular, there is much debate over substitution practices. Substitution describes the practice where a pharmacist decides to change a product, dispensing an equivalent (generic small molecule) or highly similar product (biosimilar) without the prescribing physician’s prior consent. This is distinct from switching, whereby a physician changes a patient’s treatment, between reference product and a biosimilar, or between biosimilars. Between March and May 2017, Pfizer conducted an internal global survey of 82 countries in which it examined biosimilar pharmacy-mediated substitution. Here, the company hoped to understand and benchmark the global policy landscape [1].

Generics versus biosimilars: pricing and usage-enhancing policies

Biosimilars/Research | Posted 23/02/2018

In Europe, pricing and demand-side measures for generic medicines are widely implemented and have undergone evaluations [1-4]. However, when it comes to biosimilars, the policies implemented by European countries are less well known and explored.

Biosimilars of denosumab

Biosimilars/General | Posted 23/02/2018

Last update: 11 December 2020

Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone.