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Momenta versus Amphastar and the safe harbour provision

Published on 2012/12/25

On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. Â§ 271(e)(1) covers post-approval testing as long as it is â€...

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Generic drug user fees come into effect

Published on 2012/12/20

Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) was approved by the US Congressâ€™s House Energy and Commerce Committee on 21 Sept...

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Generic medicine switches confuse patients and reduce adherence

Published on 2012/12/18

Switching between generic medicines without explaining the reason to the patient can undermine trust in pharmacists, the Aston Medication Adherence Study (AMAS) has found. The purpose of the research...

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India plans further cuts to drug prices

Published on 2012/12/12

The Indian government has announced plans to further extend price cuts on both generic and brand-name drugs in order to try to improve access to affordable medicines in the country. According toÂ T...

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FDA gives generics greater importance

Published on 2012/12/10

The Office of Generic Drugs has been promoted to the highest position within FDA because of the great amount of work and income/expenditure now associated with generics. The Office of Generic Drugs...

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Overview of research on biosimilarity/comparability and interchangeability of biosimilars 2012

Published on 2012/12/07

Period: January to August 2012Â After the patent on a biological medicine expires â€˜similarâ€™ versions of the originator biological can be produced. These biosimilars or â€˜similar ...

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The Common European Submission Platform

Published on 2012/12/05

The Heads of Medicines Agencies (HMA) is currently carrying out an â€˜extended proof of conceptâ€™ for the Common European Submission Platform (CESP) project aimed at establishing a single po...

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Suggestions for increasing generics use in Abu Dhabi

Published on 2012/12/03

This concluding article in a series of three suggests ways of improving the use of generics in Abu Dhabi. Potential benefits from a changed situationLimited demand-side measures have led to increased...

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Australian patients â€˜very positiveâ€™ about generics

Published on 2012/11/30

A new survey shows 75% of Australians believe that the government should offer a price discount to consumers who choose generics. Generics are popular with patients and the governmentGeneric medicine...

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Overview of research on safety and immunogenicity of biosimilars in 2012

Published on 2012/11/29

Period: January to August 2012Â Biosimilars or â€˜biosimilar medicinal productsâ€™ are medicinal products that are similar (but not identical) in terms of quality, safety and efficacy to ...

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EMA publishes revised biosimilar Q&A document for patients

Published on 2012/11/28

On 27 September 2012 EMA published its revised Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public. The revised and updated document (EMA/837805/...

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EMA to accept biosimilar reference medicines from outside EEA

Published on 2012/11/27

EMA announced on 28 September 2012 that it has adapted its guidance in order to make it easier for new biosimilar products to be approved in the EU. The changes in policy mean that EMA will accept cli...

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