Two countries that were affected by the recent economic recession in different ways, and amended their pharmaceutical policies very differently, have provided researchers with an invaluable data set pointing to the strengths and weaknesses of contrasting pharmaceutical sector policies. The use of antipsychotic medicines across Finland and Portugal following the recession has been analysed in […]
It is far from clear whether off-patent biological medicines can offer the same cost savings as those offered by off-patent non-biological (chemically derived) medicines, write a group of Brussels-based health economists in the European Journal of Health Economics. Several key factors will play a role in realizing the potential of these effective low-cost agents, including […]
The European Medicines Agency recommends the use of pharmacodynamics (PD) markers when establishing biosimilarity, but no such biomarkers are known for the clinical efficacy of bevacizumab (Avastin). For this reason, confirmatory clinical efficacy studies are essential, write Hans Ebbers et al. of Utrecht University in The Netherlands [1]. The biosimilar monoclonal antibodies (mAb) guideline released […]
The approval of biosimilars in the European Union (EU) is governed by the EU biosimilar framework released in 2004. But new arrivals on the biosimilar stage – monoclonal antibodies – are forcing regulatory authorities to reconsider what constitutes a biosimilar, writes Dr Ebbers and co-authors [1]. Many monoclonal antibodies (mAbs) will lose patent protection in […]
Epilepsy features the unpredictable onset of seizures that can be devastating to a patient’s quality of life. Fortunately there are medications available to control the onset of seizures. But because these have to be taken over the long term, healthcare providers need to consider whether to take advantage of cheap generic alternatives to brand-name antiepileptic […]
Many healthcare professionals remain concerned about the safety and efficacy of biosimilars, and are hence reluctant to prescribe them for patients, despite the publication of guidelines for their approval by European regulatory authorities. This level of distrust may reflect a lack of engagement by the regulatory authorities with the medical community during the development of […]
Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care Oncologists have been urged to embrace biosimilar drug substitution to help control the spiralling costs of cancer care. However, they have been warned that the optimal realisation of such a programme requires successful educational initiatives and the development of effective working partnerships with pharmacists and patients [1]. […]
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