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FDA guidance sought on false and misleading information on biosimilars Biosimilars/General | Posted 07/09/2018

Pharma giant Pfizer has asked the US Food and Drug Administration (FDA) to issue guidance ‘clarifying appropriate sponsor communications about the nature and properties of biosimilars’.

Trastuzumab and Bevacizumab products approved in Australia and Argentina Biosimilars/News | Posted 07/09/2018

Australia has approved a trastuzumab biosimilar and Argentina has approved a bevacizumab medicamento biológico similar.

FDA significantly increases generic user fees in 2019 Generics/General | Posted 07/09/2018

The US Food and Drug Administration (FDA) has increased the amount that generics manufacturers will have to pay for large-size operation generic drug applicants by more than US$270,000 for fiscal y...

Co-development deal for ranibizumab biosimilar Xlucane Pharma News | Posted 07/09/2018

German generics giant Stada and Swedish biotech company Xbrane announced on 12 July 2018 that they had entered into a co-development agreement for Xlucane, a proposed biosimilar to Lucentis (ranibi...

Pooled analysis results of adalimumab, etanercept and infliximab biosimilars Biosimilars/Research | Posted 07/09/2018

South Korean electronics giant Samsung and biotechnology company Biogen Idec (Biogen) joint venture Samsung Bioepis, along with Biogen, announced on 13 June 2018 results of a pooled analysis combin...

Generic diabetes and cancer drugs pose challenge to Bristol-Myers Squibb and Eli Lilly Generics/News | Posted 07/09/2018

Generics manufacturers in Bangladesh and Germany have recently announced the launch of generic versions of Bristol-Myers Squibb’s diabetes treatment Glucophage and Eli Lilly’s lung cancer drug Peme...

Comparison of trial and real-world data for biosimilar filgrastim Biosimilars/Research | Posted 07/09/2018

A study carried out by researchers from Germany compared results from a randomized controlled trial (RCT) of Sandoz’s biosimilar filgrastim and post-approval data on the safety of the biosimilar [1].

Addressing uncertainty in biosimilarity Reports | Posted 07/09/2018

How to address uncertainty in biosimilarity was a subject discussed by Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA) during the Drug Information Associatio...