Biosimilars

Timing of the launch of biosimilars in Europe

Biosimilars/Research | Posted 12/08/2011

When and where to launch a new biosimilar to ensure that its uptake is the most effective throughout Europe is an issue that affects all pharmaceutical companies working on biosimilars [1].

How cheap will biosimilars need to be

Biosimilars/Research | Posted 05/08/2011

What level of discounts will biosimilars need to provide to be competitive? Some believe that biosimilars will need to provide substantial discounts, being priced as low as 25%, and not 75%, of the originator price [1].

The market for biosimilars

Biosimilars/Research | Posted 29/07/2011

How do the different markets respond to biosimilars? Markets with strong generic adoption frameworks are likely to have good biosimilar adoption as well. However, physician willingness to adopt may be a barrier to entry [1].

Biosimilar regulatory issues

Biosimilars/Research | Posted 08/07/2011

In Europe, the regulatory frameworks for biosimilars are largely established, with both general guidelines and product specific guidelines put in place by the EMA, covering human insulin, somatropin, human growth hormone, erythropoietin, interferon-alpha, low molecular weight heparin and monoclonal antibody. The agency is also currently working on draft guidelines for a number of other product class specific guidelines, including interferon-beta and follicle stimulation hormone.

Biosimilars approved in Europe

Biosimilars/General | Posted 08/07/2011

Last update: 28 January 2025

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

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.