Biosimilars

Regulatory approach to biosimilar development

Biosimilars/Research | Posted 20/05/2011

Legislation in Europe in 2004 created a legal pathway for approval of biosimilars and the first biosimilar, Omnitrope (somatropin) as approved by the EMA in 2006. The US is lagging behind somewhat, having only just approved a legal pathway in March 2010 and with practical guidance from the FDA still anticipated.

Quality attribute changes for rituximab

Biosimilars/Research | Posted 20/05/2011

Last updated: 4 April 2013

Sandoz researchers found quality changes in commercially available rituximab (Rituxan/Mabthera) over a period of time. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities.

Questions over US biosimilars pathway in light of Teva’s BLA

Biosimilars/General | Posted 20/05/2011

Questions have arisen over whether the abbreviated pathway for approval of biosimilars in the US will ever be used. Many believe that biosimilars manufacturers will opt out of this pathway and use the normal route via a Biologic License Application (BLA). This is backed up by the fact that Teva’s biosimilar, Neutroval, was submitted to the FDA via the normal BLA route.

TNF copy biological approved in China

Biosimilars/News | Posted 20/05/2011

China-based Simcere Pharmaceutical Group (Simcere) announced on 9 May 2011 that Shanghai Celgen Bio-Pharmaceutical (Shanghai Celgen) has received approval for Qiangke – a copy biological version of etanercept – by the Chinese authorities.

Comparability for biosimilar development

Biosimilars/Research | Posted 13/05/2011

How does ‘comparability’ apply to biosimilar drug development? This was the question discussed by Dr Mark McCamish and Dr Gillian Woollett [1].

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 biological drug developers.

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 would indicate that the changes were accepted by the health authorities [1].

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, of Abbott’s monoclonal antibody Humira (adalimumab).

Acceptable changes in quality for glycosylated biologicals

Biosimilars/Research | Posted 06/05/2011

Research carried out by Sandoz into three glycosylated protein biotechnology drugs currently on the market showed quality changes over the period studied. Since all three drugs remained on the market with unchanged labels, this would indicate that the changes were accepted by the health authorities [1].

Opportunities for biosimilar development

Biosimilars/Research | Posted 06/05/2011

Rising drug costs and limited healthcare budgets across the world, coupled with the fact that many biotechnology drugs will soon lose their patent protection, means that there is a huge opportunity for biosimilar manufacturers.