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Attitudes towards prescribing generics in Malaysia

Published on 2012/05/04

A recent study carried out in Malaysia has shown that pharmacists in the country have a lack of confidence in generic medicines produced by local pharmaceutical companies. The generics market in Mala...

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EMA released pharmacovigilance guidelines for public consultation

Published on 2012/05/03

EMA has released its first batch of guidelines on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012. Each of the seven pharmacovigilance modules released by EMA cover...

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Reimbursement of biosimilars

Published on 2012/05/02

The evidence required to obtain marketing authorisation for a biosimilar by the regulatory authority is not always the same as that required by the reimbursement authority. This can cause problems for...

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Biosimilars will not be able to use ANDA pathway to approval

Published on 2012/04/30

FDAâ€™s highly anticipated guidance for biosimilars finally arrived on 10 February 2012 with the release of three draft guidance documents. Some have complained that the guidance is too vague, ho...

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FDA announces public hearing on biosimilarsâ€™ guidelines

Published on 2012/04/27

FDA has announced a one-day public hearing to be held on 11 May 2012, in Silver Spring, Maryland, USA. During the meeting FDA hopes â€˜to obtain input on recently issued draft guidelines relating ...

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Pricing of biosimilars

Published on 2012/04/25

For small molecule generics, reductions in price of around 80% have been observed after the first six months to a year of generics entry to the market in countries such as Germany, UK and the US. Bios...

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Brand-name atorvastatin cheaper than generics

Published on 2012/04/23

Despite generics of Pfizerâ€™s blockbuster cholesterol-reducing drug Lipitor (atorvastatin) being available in the US since the patent expired in November 2011, many patients are still receiving ...

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Canadaâ€™s generics and brand-name pharma come together to tackle drug shortages

Published on 2012/04/20

Canadaâ€™s Research-Based Pharmaceutical Companies (Rx&D) and the Canadian Generic Pharmaceutical Association (CGPA) announced on 12 March 2012 their commitment and financial support in respo...

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Generics reach 80% and play a critical role in reducing costs

Published on 2012/04/19

Prescription drug spending in the US reached US$307 billion in 2010â€“an increase of US$135 billion since 2001â€“and comprised approximately 12% of all healthcare spending in the country, ac...

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AARP report highlights importance of generics

Published on 2012/04/18

According to a report issued on 6 March 2012 by AARP (formerly the American Association of Retired Persons) the prices of drugs used most widely by older Americans rose by nearly 26% from 2005 to 2009...

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Indian Government issues first compulsory licence

Published on 2012/04/16

The Indian Government has issued a compulsory licence for the first time, allowing India-based drugmaker Natco Pharma (Natco) to launch a generic version of Bayerâ€™s liver and kidney cancer drug...

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Data publication may address generic misperceptions

Published on 2012/04/13

Wider publication of bioequivalence, safety, or efficacy data to demonstrate the effectiveness of generic drug compounds may help to nullify the last remaining anti-generics argument: that generics do...

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