[Ip-health] Cell line access to revolutionize the biosimilars market
dzintarsgotham at gmail.com
Thu May 3 07:11:02 PDT 2018
I would like to share a short opinion piece published today on how the biosimilars market could be improved by removing barriers relating to trade secrets and lack of access to originator cell lines. The proposal is backed up with a illustration of biologic manufacturing costs, which are widely discussed in industry literature, but rarely highlighted in policy or clinical fora. There would doubtless be a huge amount of political, legal, and scientific work needed to move towards a system like this, and I would be very interested to hear about any work being planned (or being done) to explore the specifics. KEI has previously proposed that cell lines and process details should be shared.
The abstract is pasted below, and the article is available at https://f1000research.com/articles/7-537/v1 . This is an open publishing/open peer review platform, and the article has not been peer reviewed yet.
Gotham D. Cell line access to revolutionize the biosimilars market [version 1; referees: awaiting peer review]. F1000Research 2018, 7:537 (doi: 10.12688/f1000research.14808.1 <http://dx.doi.org/10.12688/f1000research.14808.1>)
Biologic drugs are notoriously expensive. Biosimilars, though priced lower, are also costly. Analysis of the cost of production of biologics suggests that the cost of manufacture is in many cases less than 10% of the price in high-income countries, and less than a third of the price of biosimilars in India. This in turn implies that the relatively high prices of biosimilars are largely due to the need to undertake laborious reverse-engineering and phase 3 trials to demonstrate clinical similarity. In this article, it is proposed that originators could be required to submit cell line stocks to regulators and disclose details of manufacturing processes. These would be shared with prospective non-originator manufacturers to greatly reduce the investments needed to bring a non-originator biologic to market. This system would allow far greater price reductions for biologics after the expiry of monopoly rights (e.g. patents), while maintaining the monopoly rights used to incentivize drug development.
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