FDA approves generic versions of blood thinner clopidogrel

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… Read More »

Bill introduced to ensure generics get 180-day exclusivity

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… Read More »

Current and future issues surrounding biosimilars

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… Read More »

Top 10 most read GaBI Online articles in 2011

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… Read More »

Patients do not talk about generics with doctors

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… Read More »

Canada drug shortages

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… Read More »

Attitudes towards prescribing generics in Malaysia

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… Read More »

EMA released pharmacovigilance guidelines for public consultation

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… Read More »

Reimbursement of biosimilars

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… Read More »

Biosimilars will not be able to use ANDA pathway to approval

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FDA’s highly anticipated guidance for biosimilars finally arrived on 10 February 2012 with the release of three draft guidance documents.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… Read More »

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