Pharma News

FDA announced on 4 February 2013 that the agency had approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).

2012 was a busy year with lots of developments in biosimilars from regulatory guidelines to comparability issues.  Biosimilars remain as the hot topic of the year for GaBI Online.

On 4 January 2013 the Alabama Supreme Court ruled that Pfizer can be sued for failing to warn about a drug’s risks by a patient who claimed he was injured by a generic version of its gastric reflux medicine Reglan (metoclopramide).

Teva Pharmaceutical Industries’ (Teva’s) new Chief Executive vowed to reshape the drugmaker and reduce annual costs by up to US$2 billion over the next five years, making it into ‘the most indispensable medicines company in the world’.

Pharma giant Eli Lilly and India-based generics manufacturer Strides Arcolab announced on 5 December 2012 a collaboration to market the latter’s generic cancer drugs in emerging markets.

Mergers are once again on the agenda as companies strive to meet the constant demands of governments to cut costs and yet still make a profit.

Healthcare major Sanofi announced on 2 October 2012 that it has signed an agreement to acquire Colombian generics manufacturer Laboratorios Genfar (Genfar), making Sanofi a market leader in Colombia and expand its portfolio of affordable pharmaceuticals in Latin America.

On 8 August 2012 the US Federal Trade Commission (FTC) issued a positive advisory opinion to the Generic Pharmaceutical Association (GPhA) approving its Accelerated Recovery Initiative (ARI), which hopes to address drug shortage issues, after the FTC found the ARI will not be anticompetitive as sensitive information will be protected.

German healthcare conglomerate Fresenius has posted substantial growth across all regions and product areas during the first half of 2012 for its US business Fresenius Kabi. The growth has been largely attributed to rivals’ problems with supplying generics on the drug shortages list in the US.

Japan has not been an easy place for drugmakers to do business. However, with government initiatives being introduced to increase generics use and taking into account the fact that Japan is currently the world’s second largest pharmaceutical market, it is perhaps not surprising that a new partnership is optimistic about the opportunities.