Biosimilars

Development of biosimilars

Biosimilars/Research | Posted 01/07/2011

Costs and risk reduction are facilitating product development of biosimilars [1].

EMA and FDA to collaborate on biosimilars

Biosimilars/News | Posted 01/07/2011

The EMA announced on 23 June 2011 that it had set up a new ‘cluster’ to collaborate with the FDA for the exchange of information on biosimilar drugs.

Current status of biosimilar development

Biosimilars/General | Posted 01/07/2011

Widespread therapeutic use of biological pharmaceutical products appears to be inevitable. Nevertheless, the law governing approval of biosimilar products in the US is still not in place. The size of the biologicals market and impending patent expiries, however, are making approval of a practical pathway for biosimilars more urgent.

Manufacturing of biosimilars

Biosimilars/Research | Posted 24/06/2011

Manufacturing of biosimilars is more challenging than the traditional small molecule generics. Some of the reasons are:

Investments (including operating costs) associated with manufacturing of biosimilars along with the risk of failure for biosimilars are significantly higher than that for small molecule generics. This results in a relatively smaller discount for biosimilars compared to small molecule generics.
Minor changes in manufacturing process can cause significant changes in efficacy or immunogenicity.
Biosimilars are larger and more complex molecules to manufacture.

Partnerships will drive biosimilar development

Biosimilars/News | Posted 24/06/2011

With biosimilars tipped to become a multibillion-dollar market in the coming years, everybody is jumping on the biosimilars bandwagon, and it seems it’s not just limited to pharmaceutical companies.

Does industry support biosimilar user fees in the US?

Biosimilars/News | Posted 24/06/2011

According to FDA, biopharmaceutical trade groups are supportive of its proposal for biosimilar user fees, with sponsors paying an up-front fee with their applications.

Challenges ahead for biosimilar development

Biosimilars/Research | Posted 17/06/2011

Biosimilars, it seems are here to stay, but there is still some way to go before they become commonplace. There is also concern over the associated costs for biological medicines. The cost of biotech therapies is expected to steadily grow by about 30% (an approximately 20 fold increase in 10 years) by 2016.