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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...

Drug companies seek to block generic version of ulcerative colitis therapy Generics/News | Posted 13/03/2015

The patent holder and manufacturer of Uceris (budesonide), a treatment for ulcerative colitis, have sued generics company Actavis for infringing their drug’s patents. Actavis recently filed an abbr...

Second Apotex biosimilar under FDA review Biosimilars/News | Posted 13/03/2015

Canada-based Apotex announced on 13 February 2015 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neupogen (filg...

Biosimilars will only be developed for blockbuster biologicals Reports | Posted 13/03/2015

A new report, published on 24 February 2015, by pharmacy benefits management (PBM) company Prime Therapeutics, suggests that only blockbuster biologicals in the US will be subject to biosimilar com...