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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....

Potential savings of Euros 72 million with more generics use in three therapeutic areas Generics/Research | Posted 13/03/2015

A nationwide cohort study in Austria reported that substituting branded medications with drugs containing the same active ingredients (generics) could save considerable amounts of money. A study at...

Huge discount on biosimilar infliximab in Norway Biosimilars/General | Posted 13/03/2015

Norway’s price regulator has been offered a discount of 72% for biosimilar infliximab in the country’s latest tender for drugs.

Mexico issues rules on biolimbos Guidelines | Posted 13/03/2015

The Mexican regulatory body for approval of medicines, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), has issued rules for older non-originator biologicals registered...