Biosimilars
A biosimilar by any other name …
Following the expiration of patents on the originator molecules, copied products have been introduced into the market. EU regulators have named these products as ‘biosimilars’, that is ‘similar biological medicinal products’; and US regulators refer to them as ‘follow-on biologics’. Specific regulatory pathways have also been established for these biosimilar products, which differ from those for ‘chemical generics’ [1].
Observations on the introduction of biosimilar epoetins into Europe
Professor Wolfgang Jelkmann of the University of Luebeck in Germany has recently published a review article summarising the experiences with biosimilars introduced in the EU after the original biopharmaceutical patents expired [1].
Timing of the launch of biosimilars in Europe
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
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
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
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
Last update: 16 July 2024
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
Costs and risk reduction are facilitating product development of biosimilars [1].
EMA and FDA to collaborate on biosimilars
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
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.
