Biosimilars
Kissei/JCR’s darbepoetin alfa biosimilar shows equivalent safety and efficacy
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
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
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
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
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.
Etanercept switching study investigates non-mandatory transitioning
A study carried out by researchers from The Netherlands investigated whether non-mandatory transitioning from originator to biosimilar etanercept improves retention rates [1].
EBE reveals Europe’s biosimilar pricing and reimbursement policies landscape
The first biosimilar was approved in the European Union (EU) in 2006. Since then, biosimilar policies have been developed with a focus on increasing biosimilar uptake. However, the extent to which EU Member State polices differentiate between biosimilars and generic medicines has been brought into question. The European Biopharmaceutical Enterprises (EBE) has conducted a second survey on pricing and reimbursement policies for off-patent biologicals to map the biosimilar policy landscape in Europe [1].
EMA approval for biosimilar insulin glargine Semglee
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 25 January 2018 that it had recommended granting marketing authorization for the insulin glargine biosimilar Semglee.
Quality and clinical performance of biopharmaceuticals
A review carried out by researchers from Sandoz describes the inherent nature of biopharmaceutical heterogeneity and discusses modern quality systems and regulatory frameworks used to maintain biopharmaceutical quality and clinical performance [1].
Zarxio reveals all: the US biosimilars market
Launched in 2015, Zarxio (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval [1]. It competes with Neupogen (its reference product), Granix and Neulasta, for a share of the neutropenia market. This approval came almost a decade after the 2006 launch of the first biosimilar in Europe. Following this, a new study has examined Zarxio’s first years’ performance in the US short-acting (SA) filgrastim market to identify key sales and marketing trends and their drivers [2].
