Biosimilars
Yoshindo and Lupin’s etanercept biosimilar completes trials
YL Biologics announced on 7 February 2018 that the global phase III trials of its etanercept biosimilar have been a success. YL Biologics is a joint venture of India’s Lupin Ltd and Japanese firm Yoshindo that was first announced in 2014 [1]. The etanercept biosimilar has met a successful outcome for rheumatoid arthritis treatment and hopes to compete for a share of the originator Enbrel’s global market of US$11 billion.
PK and PD comparison between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients
A requirement for registration of a biosimilar is to demonstrate pharmacokinetic (PK) similarity with the reference product. A population PK model approach is an excellent method for assessing PK similarity, in contrast to the classical one, because it allows comparison of PK properties through the inclusion of sparse data that improves the power to detect any potential differences between the biosimilar and the reference product. Furthermore, the population approach allows quantification of the inter-product and inter-subject variability of PK parameters and identification of covariate factors (demographic, pathophysiological, environmental or concomitant drugs) that influence drug availability [1].
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].
Insulin glargine biosimilar gains South Korean approval
South Korea-based GC Pharma (formerly Green Cross Corporation) announced on 8 March 2018 that it had received approval for its insulin glargine biosimilar Glarzia from the Korean Ministry of Food and Drug Safety (MFDS).
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].
US drug contracting system is ‘rigged’ against biosimilars
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
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
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
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
Indian generics maker Cadila Healthcare (Cadila) and Indonesia-based Kalbe Farma (Kalbe) are both making advances into the biosimilars field.
