News
Brand-name drugmaker can be sued for harm caused by generic drug
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… Read More »
Overview of research on analytical techniques in the manufacturing of biosimilars in 2012
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… Read More »
Brand-name and generics labels don’t match
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… Read More »
Patients persuade doctors to prescribe brand-name rather than generic drugs
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… Read More »
CCM and Biocon make biosimilar insulin deal
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,… Read More »
French Government pushing generics
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… Read More »
Significance of locally produced biosimilars in Iran
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,… Read More »
Biosimilar monoclonal antibodies on the horizon in Europe
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… Read More »
EMA publishes draft guideline for biosimilar human insulin
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… Read More »
Originator biologicals approved and marketed in Germany
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.… Read More »
