More Articles

Biosimilars user fees as high as brand-name fees Biosimilars/News | Posted 13/05/2011

On 9 May 2011, the FDA proposed a user fee programme that would see drugmakers seeking approval to market biosimilars in the US initially paying fees similar to those required of originator biologi...

Generics grab 80% share of US market and fill 78% of prescriptions Reports | Posted 13/05/2011

As more brand-name drugs lose patent protection, use of less expensive generics continues to rise. A new report, published in April 2011 by IMS Health, shows a slowdown in US spending on drugs, but...

Changes in the quality attributes of darbepoetin alfa Biosimilars/Research | Posted 13/05/2011

Quality changes over a period of time were found in commercially available darbepoetin alfa (Aranesp) by Sandoz researchers. Since the drug remained on the market with an unchanged label, this woul...

Concerns over international reference pricing in the EU Generics/General | Posted 13/05/2011

An independent report commissioned by the European Parliament’s committee for Environment, Public Health and Food Safety (ENVI) has highlighted some problems with access to medicines due to the wid...

EMA, FDA and TGA joint GMP inspection programme Guidelines | Posted 13/05/2011

On 27 April 2011, the FDA announced that it is working with the EMA and Australia’s Therapeutic Goods Administration (TGA) to finalise a permanent pilot programme for joint good manufacturing pract...

Generic substitution rates in South Africa Generics/Research | Posted 13/05/2011

Research carried out by the School of Pharmacy at the North-West University, South Africa, has shown that generic substitution rates for antidepressants increased between 2004 and 2006. Meanwhile a...

Brazil to manufacture follow-on adalimumab Biosimilars/News | Posted 13/05/2011

The Brazilian Ministry of Health (Ministério da Saúde) announced on 5 April 2011 that it would be entering into an agreement with PharmaPraxis to manufacture a biosimilar, or follow-on version...

Ranbaxy launches generic olanzapine in Spain Generics/News | Posted 13/05/2011

Eli Lilly may be facing pressure as generics makers queue up to produce copies of its blockbuster antipsychotic drug Zyprexa (olanzapine). On 25 April 2011,the first day after Eli Lilly’s patent ex...