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Stada and Richter to collaborate on biosimilar development

2011-09-12 German generics giant Stada Arzneimittel (Stada) and Hungary-based Gedeon Richter (Richter) announced on 30 August 2011 that the two companies have signed licence an...
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Is FDA requesting too much data to allow biosimilars to succeed in the US

2011-09-12 The FDA’s recently published plans for a biosimilar approval pathway are facing increasing scrutiny. In an interview with Scientific American, Novel Health Strategie...
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New Spanish prescribing laws to promote generics

2011-09-09 In an attempt to reduce the healthcare bill the Spanish government has approved new rules to force Spanish doctors to prescribe and pharmacies to dispense generic dr...
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Benefits of generics called into question

2011-09-09 The benefits associated with generic prescription drugs have been called into question in an article published in the British Medical Journal (BMJ) [1].Dr Douglas Ka...
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Generics manufacturers do not have to change drug safety labels in the US

2011-09-07 A landmark ruling from the US Supreme Court has decided that generic drug manufacturers do not have to change their drug’s safety label, even if stronger safety warn...
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GPs in the UK to be banned from prescribing branded statins

2011-09-07 General Practitioners (GPs) in Cambridgeshire, UK, have been told by the national health service (NHS) that they are considering proposals to ban prescribing of bran...
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Does switching to generic anti-epileptic drugs lead to loss of seizure control

2011-09-05 Patients with epilepsy may have a higher risk of seizures if they switch from their brand-name medication to generic anti-epileptic drugs (AEDs). This is the message...
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Biosimilars approved in Europe

2011-09-05 Last update: 11 October 2011In the EU, a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approve...
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Need for a global pathway for biosimilars

2011-09-02 The need for access to biosimilars is global, yet the regulations are national. Issues with this approach are discussed by Dr Mark McCamish and Dr Gillian Woollett i...
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Merck and Parexel form strategic alliance for biosimilars

2011-09-02 Merck Sharp and Dohme (MSD – known in the US and Canada as Merck) and Parexel, a leading global biopharmaceutical services provider, announced on 12 January 2011 tha...
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Switching from a brand-name antiepileptic drug to a generic is not associated with a higher risk of seizures

2011-08-31 A report in Clinical Pharmacology and Therapeutics provides further evidence that patients with epilepsy do not have a higher risk of seizures if they switch from th...
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Epilepsy: medical concerns of prescribing generics

2011-08-31 Generic economicsGeneric medications are generally cheaper than their branded product counterparts and so prescribing these is encouraged as a cost-containment strat...
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