More Articles

EMA released pharmacovigilance guidelines for public consultation Guidelines | Posted 30/03/2012

EMA has released its first batch of guidelines on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012.

Reimbursement of biosimilars Biosimilars/Research | Posted 30/03/2012

The evidence required to obtain marketing authorisation for a biosimilar by the regulatory authority is not always the same as that required by the reimbursement authority [1]. This can cause probl...

Biosimilars will not be able to use ANDA pathway to approval Biosimilars/General | Posted 30/03/2012

FDA’s highly anticipated guidance for biosimilars finally arrived on 10 February 2012 with the release of three draft guidance documents [1]. Some have complained that the guidance is too vague, ho...

Top 10 most read GaBI Online articles in 2011 Pharma News | Posted 30/03/2012

2011 was a busy year and biosimilars was the hot topic of the year for GaBI Online.

Also noted on biosimilars: 30 March 2012 Biosimilars/General | Posted 30/03/2012

Bioequivalence of biosimilar trastuzumab to Herceptin proven in phase I trialBiopharmaceutical company Synthon announced on 22 March 2012 that all in vitro and in vivo studies conducted so far hav...

FDA approves first generic ibandronate sodium osteoporosis drugs Generics/News | Posted 30/03/2012

FDA announced on 19 March 2012 the approval of the first generics of GlaxoSmithKline’s and Roche’s postmenopausal osteoporosis drug Boniva (ibandronate sodium).

Fujifilm and Kyowa launch biosimilars joint venture Biosimilars/News | Posted 30/03/2012

The Japanese digital camera maker Fujifilm Corporation (Fujifilm) and biotech firm Kyowa Hakko Kirin (Kyowa) announced on 27 March 2012 that they have launched their biosimilars joint venture, whic...

Also noted on generics: 30 March 2012 Generics/General | Posted 30/03/2012

Watson in talks to buy ActavisUS generics manufacturer Watson is rumoured to be making a bid for Icelandic generics company Actavis, according to Bloomberg, creating one of the world’s largest gen...