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US prescribers’ views on the naming and labelling of biologicals Biosimilars/Research | Posted 14/07/2017

The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey in which they asked 400 US physicians for their views on the labelling of biosimilar medicines, and a separate...

Daiichi Sankyo ends deal with Coherus for etanercept biosimilar in Japan Pharma News | Posted 14/07/2017

Daiichi Sankyo announced on 5 July 2017 that it was ending its co-development in Japan with Coherus BioSciences (Coherus) of a biosimilar to Amgen’s arthritis drug Enbrel (etanercept).

Real world switching data for etanercept biosimilar Benepali Biosimilars/Research | Posted 14/07/2017

Real world evidence from a study of etanercept biosimilar Benepali (SB4) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have demonstrated ‘sustained efficacy and safety, and h...

FDA rejects Pfizer’s epoetin alfa biosimilar Biosimilars/News | Posted 14/07/2017

US pharma giant Pfizer announced on 22 June 2017 that the US Food and Drug Administration (FDA) had rejected its application for approval of its epoetin alfa biosimilar.

Follow-up study finds generic tacrolimus safe for kidney transplant patients Generics/Research | Posted 14/07/2017

Researchers from Portugal, who carried out a long-term follow-up study, have found that switching stable kidney transplant patients to generic tacrolimus is safe [1].

US states progress drug pricing legislation Policies & Legislation | Posted 14/07/2017

With attention being increasingly focussed on the price of drugs in the US, and with federal action on drug prices and cost transparency having stalled in Congress, several states have moved forwar...

Biocad registers rituximab similar biotherapeutic product in Bolivia and Honduras Biosimilars/News | Posted 14/07/2017

Russian biotechnology company Biocad announced on 6 June 2017 that it had obtained a marketing authorization for its rituximab ‘similar biotherapeutic product’ in Bolivia and Honduras under the tra...

FDA releases 37 new and revised bioequivalence guidelines for generics Guidelines | Posted 14/07/2017

As part of its ongoing efforts to provide product-specific guidance for generics makers the US Food and Drug Administration (FDA) has again released several new and revised bioequivalence documents...