Generics/General

Indian Government issues first compulsory licence

Generics/General | Posted 16/03/2012

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 Nexavar (sorafenib) before the patent expires on the originator.

Also noted on generics: 16 March 2012

Generics/General | Posted 16/03/2012

Prescription drugs to be directly dispensed by pharmacists
FDA has announced a meeting to be held on 22 and 23 March 2012 to discuss the possibility of allowing some prescription drugs to be dispensed by pharmacists without the need for a physician’s prescription.

Source: Federal Register

FDA approves new suppliers to alleviate cancer drug shortages

Generics/General | Posted 02/03/2012

Two new suppliers of cancer treatments have been approved by FDA to try to alleviate ongoing US drug shortages.

WHO definitions of generics

Generics/General | Posted 24/02/2012

Confusion often surrounds terms used in the global field of generics and biosimilars.

Commission urges Greece to make parallel trade fair

Generics/General | Posted 24/02/2012

The European Commission announced on 26 January 2012 that it wanted Greece ‘to establish fair play on parallel importation of medicinal products’.

Italian physicians’ negative attitude to generics

Generics/General | Posted 17/02/2012

A row over generics prescribing has erupted in Italy, with the government and physicians at odds over changes to prescribing rules.

The pharmaceutical market in Brazil

Generics/General | Posted 09/12/2011

The Brazilian pharmaceutical market is the third largest in the Americas region, after Canada and USA, it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuelled by increasing disposable income, therefore, the market outlook is positive for the 2011–2016 period.

European Commission investigates Johnson & Johnson and Novartis over delaying generics

Generics/General | Posted 28/10/2011

As part of its ongoing antitrust investigations, the European Commission (EC) announced on 21 October 2011 that it is looking into agreements between Johnson & Johnson (J&J) and Novartis to determine whether they delayed the entry of a generic version of the fentanyl painkiller in The Netherlands. If the drugmakers had ‘contractual arrangements’ that hindered a generic drug, this would ‘potentially’ breach EU antitrust rules.

Quality by design for generics by 2013

Generics/General | Posted 09/12/2011

Quality by design (QbD) is already being implemented by FDA for new drug applications, but now, in an attempt to prepare generics manufacturers for QbD in 2013, FDA is preparing to publish immediate and modified release QbD examples.

European Commission to investigate patent settlements again

Generics/General | Posted 04/03/2011

The European Commission (EC) has once again requested information from pharmaceutical companies regarding patent settlement agreements concluded in the European Economic Area (EEA) in 2010 between originator and generic companies.