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Pfizer carrying out biosimilar trastuzumab trial in US Biosimilars/Research | Posted 19/10/2012

Pharma giant Pfizer is carrying out a phase I trial in the US for a biosimilar version of trastuzumab.

Biosimilars applications under review by EMA Biosimilars/General | Posted 19/10/2012

Last update:  11 January 2013 EMA is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 2003.  Approval of...

Generic medicine switches confuse patients and reduce adherence Reports | Posted 19/10/2012

Switching between generic medicines without explaining the reason to the patient can undermine trust in pharmacists, the Aston Medication Adherence Study (AMAS) has found [1].

Mergers between Watson/Actavis and ANI Pharma/BioSante Pharma News | Posted 19/10/2012

Mergers are once again on the agenda as companies strive to meet the constant demands of governments to cut costs and yet still make a profit.

Medicago and Cellectis in successful biosimilars research collaboration Biosimilars/News | Posted 19/10/2012

Canadian biopharmaceutical company Medicago and Cellectis plant sciences, a subsidiary of Cellectis SA, French genome engineering specialist, announced on 4 October 2012 the successful completion o...

Generic drug user fees come into effect Policies & Legislation | Posted 19/10/2012

Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) was approved by the US Congress’s House Energy and Commerce Committee on 21 Septembe...

The Common European Submission Platform Guidelines | Posted 12/10/2012

The Heads of Medicines Agencies (HMA) is currently carrying out an ‘extended proof of concept’ for the Common European Submission Platform (CESP) project aimed at establishing a single portal for e...

Overview of research on biosimilarity/comparability and interchangeability of biosimilars 2012 Biosimilars/Research | Posted 12/10/2012

Period: January to August 2012 After the patent on a biological medicine expires ‘similar’ versions of the originator biological can be produced. These biosimilars or ‘similar biological medic...