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Health Canada clamps down on GMP compliance Generics/General | Posted 20/03/2015

Canada’s federal health department Health Canada has written to its licensed drug and active pharmaceutical ingredients (API) manufacturers worldwide reminding them of their regulatory responsibili...

Infliximab biosimilars tighten grip on European markets Biosimilars/News | Posted 20/03/2015

The progress of biosimilars onto the European market continues apace with an announcement from Mundipharma that Remsima (infliximab biosimilar) is being launched in several major markets, including...

California and Illinois consider biosimilar substitution bills Policies & Legislation | Posted 20/03/2015

In the ongoing saga in the US over biosimilars substitution, California and Illinois are the latest states to be considering legislation which will allow the substitution of biosimilars at the phar...

FDA plans to release four biosimilar guidances during 2015 Guidelines | Posted 20/03/2015

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to release four new guidance documents on biosimilars during calendar year 2015.

Boehringer Ingelheim loses patent battle with India’s Cipla Pharma News | Posted 20/03/2015

German pharmaceutical company Boehringer Ingelheim (Boehringer) has lost its patent on the Spiriva respiratory drug in India. The Indian patent office has agreed with the Indian drugmaker Cipla tha...

Ranbaxy fails to reverse FDA decision over Valcyte and Nexium Generics/News | Posted 20/03/2015

Indian generics company Ranbaxy has yet again failed in its bid to become the first company in the US to sell generic versions of the AstraZeneca blockbuster acid-reflux drug Nexium (esomeprazole)...

FDA approves its first biosimilar Biosimilars/News | Posted 13/03/2015

The US Food and Drug Administration (FDA) announced on 6 March 2015 that it had approved Zarxio (filgrastim-sndz) injection, the first biosimilar ever to be approved in the US, for the five indicat...

Equivalent safety and efficacy of nephrology subsequent entry biologics in Canada Biosimilars/Research | Posted 13/03/2015

A review of efficacy and safety data for subsequent entry biologics (SEBs) used in nephrology practice in Canada has found little clinical difference between epoetin SEBs and the reference product....