Home / Biosimilars / Research


Follow-on biologicals and extrapolation in Brazil

Researchers from Brazil discuss the country’s approach to follow-on biologicals and extrapolation of indications in the country [1].

Biosimilar policies around the globe

With the authorization of an increasing number of biosimilars, and the prospect of multiple biosimilar switching, biosimilar naming and the importance of this for pharmacovigilance are coming into sharper focus.  Authors from around the world considered various biosimilar issues/policies in different countries and regions [1].

ASCO issues position statement on biosimilars in oncology

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].

Use and cost of biologicals for cancer treatment in Southern Italy

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].

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].

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.

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.

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].

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].

Generics News Research General


Biosimilars News Research General