News

Pay-for-delay on the increase in the US

Published on 2013/03/25

During 2012 the number of potentially anticompetitive patent dispute settlements between brand-name and generics companies in the US increased significantly compared with 2011 according to a new repor...

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Biosimilarity and interchangeability under the BPCI Act

Published on 2013/03/22

In the US, the Biologics Price Competition and Innovation (BPCI) Act was signed into law on 23 March 2010, giving FDA the authority to approve biosimilars. FDA then issued guidelines for biosimilar ap...

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Brand-name drugmaker can be sued for harm caused by generic drug

Published on 2013/03/20

On 4 January 2013 the Alabama Supreme Court ruled that Pfizer can be sued for failing to warn about a drug’s risks by a patient who claimed he was injured by a generic version of its gastric reflux ...

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Overview of research on analytical techniques in the manufacturing of biosimilars in 2012

Published on 2013/03/18

Period: January to August 2012  Biologicals are large, complex and heterogeneous proteins with variable molecular weights, typically ranging from 18,000 to 45,000 Da. The active substance of a biolo...

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Brand-name and generics labels don’t match

Published on 2013/03/15

According to US federal law generics manufacturers have to have the same labelling as their brand-named counterparts. However, a new study has found that in practice this is often not the case. The s...

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Patients persuade doctors to prescribe brand-name rather than generic drugs

Published on 2013/03/13

Doctors are persuaded by patients to prescribe brand-name drugs when generic drugs are available. That is according to results of a survey carried out by researchers from the Harvard Medical School an...

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CCM and Biocon make biosimilar insulin deal

Published on 2013/03/11

Malaysia-based Chemical Company of Malaysia Berhad (CCM), announced on 14 December 2012 an agreement between its subsidiary, CCM Pharmaceuticals Sdn Bhd (CCMP), and India-based Biocon, giving CCMP exc...

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French Government pushing generics

Published on 2013/03/08

The French are in general mistrusting of generics with many choosing to stay with brand-name drugs. However, with rising healthcare costs and austerity measures hitting healthcare budgets, the French ...

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Significance of locally produced biosimilars in Iran

Published on 2013/03/06

Biopharmaceuticals, drugs produced by live cell culture, have a fast growing market for the treatment of a range of conditions. Despite their clinical importance, however, their cost could impose an i...

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Biosimilar monoclonal antibodies on the horizon in Europe

Published on 2013/03/04

European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted the final guideline on biosimilar monoclonal antibody (mAb) and it came into effect in December 2012. The agenc...

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EMA publishes draft guideline for biosimilar human insulin

Published on 2013/03/01

EMA announced on 14 December 2012 that it had published a draft guideline revising its current guideline on the non-clinical and clinical development of biosimilar human insulin and insulin analogues....

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Originator biologicals approved and marketed in Germany

Published on 2013/02/27

Last updated: 14 December 2012  The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for the approval, i.e. marketing auth...

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