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Regulation and uptake of ‘similar biologics’ in India Biosimilars/Research | Posted 11/12/2015

India has, by far, demonstrated the greatest acceptance of ‘similar biologics’. But what are the drivers and the limitations to the ‘similar biologics’ market in India? This is a question Dr Nagara...

Teva and Takeda partner for generics in Japan Pharma News | Posted 11/12/2015

Israeli generics giant Teva Pharmaceutical Industries (Teva) and Japan-based Takeda Pharmaceutical (Takeda) announced on 30 November 2015 that they had made a partnership to provide generics in Japan.

Further problems for Indian manufacturing sites Policies & Legislation | Posted 11/12/2015

The US Food and Drug Administration (FDA) has written to Sandoz after identifying significant violations of current good manufacturing practice (cGMP) at two of the company’s manufacturing sites in...

Assessing the immunogenicity of monoclonal antibodies Biosimilars/Research | Posted 04/12/2015

Safety is a major concern when it comes to biologicals (including biosimilars) and the most critical safety concern is immunogenicity. This is especially important in monoclonal antibody (mAb) biol...

Policies to lower prices of generics in Austria and Finland Generics/Research | Posted 04/12/2015

In this era of austerity many governments have introduced policies aimed at reducing the price of generics. In Austria, measures taken to reduce the cost of medicines include generic price linkage....

Positive phase III results for adalimumab biosimilar Biosimilars/Research | Posted 04/12/2015

US-based biologicals giant Amgen announced on 9 November 2015 that results from a phase III study of its adalimumab biosimilar (ABP 501) had ‘met the primary endpoint’.

FDA accepts application for pegfilgrastim biosimilar Biosimilars/News | Posted 04/12/2015

Sandoz, the generics division of Novartis, announced on 18 November 2015 that its regulatory submission for its proposed pegfilgrastim biosimilar had been accepted by the US Food and Drug Administr...

Infliximab price wars Biosimilars/News | Posted 04/12/2015

Merck has reportedly slashed the price of its blockbuster Remicade (Infliximab) in the UK in order to fight off growing competition from infliximab biosimilars.