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Biosimilars compared to generics in the European market Biosimilars/Research | Posted 13/02/2015

Once a patent expires, price competition is possible since any manufacturer can copy the originator product. This circumstance justifies the place in the pharmaceutical market for generics and bios...

FDA advisers to consider infliximab biosimilar Biosimilars/News | Posted 13/02/2015

The US Food and Drug Administration (FDA) revealed in a Federal Register publication on 10 February 2015 that it has asked advisers to review a second biosimilar application.

EMA explains redaction of AbbVie’s data Policies & Legislation | Posted 13/02/2015

The European Medicines Agency (EMA) has been criticized for the way it has implemented new European transparency rules for pharmaceuticals and in particular for its redaction of clinical study repo...

Biosimilars of infliximab Biosimilars/General | Posted 13/02/2015

Last update: 11 August 2017Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, C...

Mylan on track to acquire Abbott generics and expand role in women’s health Pharma News | Posted 13/02/2015

The European Commission (EC) has approved Mylan’s acquisition of Abbott Laboratories' Non-US Developed Markets Specialty and Branded Generics Business (Abbott EPD-DM), subject to conditions. US-bas...

Dr Reddy’s could move manufacturing site with view to FDA approval Generics/News | Posted 13/02/2015

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s), determined not to lose out on US Food and Drug Administration (FDA) approval for its generic version of the acid-reflux blockbuster Nexiu...

Torrent licenses three ‘similar biologics’ from Reliance Biosimilars/News | Posted 13/02/2015

Torrent Pharmaceuticals (Torrent) announced on 25 December 2014 that it had made an exclusive licensing agreement with fellow Indian drugmaker Reliance Life Sciences (Reliance) for the marketing of...

US pay-for-delay deals decrease in 2013 Reports | Posted 13/02/2015

During 2013, companies filed a total of 145 final patent dispute settlements, of which 29 were potentially anticompetitive or ‘pay-for-delay’ agreements between brand-name and generics companies, a...