Biosimilars
China’s 5-year biotech investment fires clear warning to US
The Chinese Government has targeted biotechnology as a ‘strategic pillar’ industry, and has pledged to spend 2 trillion yuan (Euros 213. 3 billion; US$308.5 billion) on science and technology in the next five years alone [1]. This has sent out a clear warning to the US Government that China aims to become the world’s pioneer in biotechnology in the short to medium term. In response, despite being under increasing pressure to reduce overall health expenditure, the US Government has resisted calls to cut funding and pledged US$ 32 billion to its National Institutes of Health biomedical research programme for 2012 [2].
Is FDA requesting too much data to allow biosimilars to succeed in the US
The FDA’s recently published plans for a biosimilar approval pathway are facing increasing scrutiny. In an interview with Scientific American, Novel Health Strategies’ biosimilar market entry advisor, Dr Saurabh Aggarwal, said that the level of data required by FDA is too much for biosimilars to be able to succeed [1].
FDA and biosimilars: process update
Despite the fact that a legal pathway for the approval of biosimilars in the US has existed for more than a year, formal guidance has still not been issued by FDA. This has led many to question when, or even if, biosimilars will come onto the market in the US [1]. So what has FDA been doing in the meantime and how close are we to seeing some biosimilar guidance in the US?
FDA gives some insight into biosimilar pathway
FDA has outlined some of the requirements it intends to include in its biosimilars approval process in an article published in the New England Journal of Medicine [1]. The article is intended to give drugmakers, investors and other interested parties more insight into the approval process for biosimilars.
EMA proposes more precise definition for biosimilars
Members of the Biosimilar Medicinal Products Working Party at the EMA expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the term biosimilar in the literature [1].
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].
