News

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

FDA’s highly anticipated guidance for biosimilars finally arrived on 10 February 2012 with the release of three draft guidance documents.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, however...

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FDA announces public hearing on biosimilars’ 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 ‘to obtain input on recently issued draft guidelines relating to t...

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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 Pfizer’s blockbuster cholesterol-reducing drug Lipitor (atorvastatin) being available in the US since the patent expired in November 2011, many patients are still receiving the b...

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Canada’s generics and brand-name pharma come together to tackle drug shortages

Published on 2012/04/20

Canada’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 responding...

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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 2010–an increase of US$135 billion since 2001–and comprised approximately 12% of all healthcare spending in the country, according to...

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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 Bayer’s liver and kidney cancer drug Nexa...

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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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