Biosimilars
EMA approval for bevacizumab biosimilar Zirabev
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 December 2018 that it had recommended granting marketing authorization for the bevacizumab biosimilar Zirabev.
Long-term follow-up of switching to biosimilar infliximab
A study of long-term follow-up data after switching to biosimilar infliximab appears to show identical retention rates, according to French researchers [1].
Trastuzumab and agalsidase beta biosimilars launched in Japan
Japanese firms have announced the launch of trastuzumab and agalsidase beta biosimilars in Japan on 28 November 2018.
Biosimilars makers in Canada to launch patient support programme
Biosimilars Canada, an association representing Canada’s biosimilar makers, announced on 22 November 2018 that it had chosen pharmaceutical service provider Innomar Strategies to be the preferred provider for the association’s Patient Support Program (PSP) platform.
WHO should finalize its BQ guidance
According to authors from the US, the World Health Organization (WHO) should finalize its Biological Qualifier (BQ) guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer of biologicals, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including those in the Middle East and North Africa (MENA) region, have access to high quality, affordable medicines [1].
British diabetologists issues position statement on biosimilar insulin
The Association of British Clinical Diabetologists (ABCD) has issued a position statement on the use of biosimilar insulin. The statement summarises information on the advantages and disadvantages of using biosimilar insulins and gives the association’s position on when biosimilar insulins be used [1].
Biosimilars launched in the US at a significant discount
Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.
Positive results for adalimumab and etanercept biosimilars from Sandoz
On 23 October 2018, Sandoz, the generics division of Novartis, presented positive phase III data for its adalimumab and etanercept biosimilars [1, 2].
FDA approves first rituximab biosimilar Truxima
On 28 November 2018, the US Food and Drug Administration (FDA) approved its first rituximab biosimilar, Truxima (rituximab-abbs), the first biosimilar for the treatment non-Hodgkin’s lymphoma (NHL).
Boehringer Ingelheim and Sandoz abandon biosimilars
Boehringer Ingelheim has decided to abandon biosimilars outside the US. While Sandoz has decided not to pursue biosimilar rituximab in the US.
