News

Abbott asks FDA to block adalimumab biosimilar

Published on 2012/06/15

Abbott Laboratories (Abbott) submitted a 30-page citizen petition to FDA on 2 April 2012 asking the agency to reject any biosimilar for its rheumatoid arthritis drug Humira (adalimumab). Abbott says t...

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EMA reviews its first biosimilar monoclonal antibody

Published on 2012/06/13

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in April 2012 the agency will be reviewing a new drug ...

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Samsung to launch biosimilars by 2015 at half the current prices

Published on 2012/06/11

South Korean electronics giant Samsung told the Financial Times that it plans to launch biosimilars by 2015 at half the prices that patients in Europe and the US currently pay. The biotechnology ar...

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Removal of barriers for the global development of biosimilars

Published on 2012/06/08

At the 2012 Biosimilars Medicines: 10th EGA International Symposium, held in London, UK, on 19–20 April 2012; Mr Nils Behrndt (Deputy Head of Cabinet DG Sanco, European Commission) announced that t...

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Biosimilars dilemma over reference products

Published on 2012/06/06

Global manufacturers of biosimilars have a dilemma on their hands concerning reference products. What to do to reduce the burden of data required in different countries and regions of the world to get...

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EMA publishes procedural advice for biosimilars

Published on 2012/06/04

On 11 April 2012, EMA published a new document on regulatory procedural advice for biosimilars. The guidance brings together a number of regulatory and procedural questions already published on the a...

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FDA approves generic versions of blood thinner clopidogrel

Published on 2012/05/23

On 17 May 2012 FDA announced the approval of a whole host of generics of Sanofi and Bristol-Myers Squibb’s blockbuster blood thinner Plavix (clopidogrel), on day one of patent expiry in the US. The...

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Bill introduced to ensure generics get 180-day exclusivity

Published on 2012/05/18

Congressman Frank Pallone and Congressman Brett Guthrie introduced a new bill to the US Senate on 29 March 2012 to amend the US Food, Drug and Cosmetic Act in order to ensure that generics manufacture...

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Current and future issues surrounding biosimilars

Published on 2012/05/16

Biological medicines are already becoming an increasingly important part of health care. With patent expiries on originator biological products, biosimilars are also increasingly become a part of this...

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Top 10 most read GaBI Online articles in 2011

Published on 2012/05/14

Generics and Biosimilars Initiative (GaBI) was founded in 2008 by Professor Huub Schellekens of Utrecht University in Utrecht, The Netherlands; Professor Arnold Vulto of Erasmus University Medical Cen...

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Patients do not talk about generics with doctors

Published on 2012/05/11

One of the main financial concerns expressed by adults in the US is the cost of medications and medical bills, however, despite this fact, very few patients talk about the price of prescription medici...

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Canada drug shortages

Published on 2012/05/07

Sandoz, the generics unit of pharma giant Novartis, is at the centre of Canadian drug shortages, however, the company is assuring Canadians that it will not raise prices of drugs sourced from overseas...

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