Generic versions of small-molecule drugs have been a fact of life for decades; the impact on the market of the first generic usually is easy to predict. In contrast, the availability of biosimilars -- ‘copies’ of biologics -- is very recent and limited so far to only a few products. Projecting the impact on markets of the appearance of ‘biosimilars’ is still difficult, both for individual products and for the market as a whole. The experience with generics may be a guide, but probably not a highly reliable one.
In June 2009, OHE held a seminar intended to encourage further thought about the distinguishing characteristics of the market for biosimilars and the implications of these for potential savings. Economists and regulatory experts in the US and Europe were invited to describe their research and offer their perspectives about what can be expected in the near- and medium-term. The presentations and discussion:
- provided an overview of the theoretical issues underpinning entry and pricing of biosimilars compared to chemical generics
- analysed examples of entry problems and regulatory hurdles associated with biosimilars
- discussed examples of pricing strategies for biosimilars in Europe
- explored the leading forecasts of US savings from biosimilars
- highlighted the issues around post-launch data collection and considered incentives to generate and use such data to affect the market share of biosimilars
- examined the efficiency of the economic options available to payers, drawing on OHE’s research on biosimilars
Since the seminar, the US has enacted the Biologics Price Competition and Innovation Act of 2009 (a subtitle of the Patient Protection and Affordable Health Care Act signed into law in March 2010). Among other things, this provides for an abbreviated approval process for biosimilars and a twelve-year data exclusivity period. Although this removes speculation about what US law may provide, implementing regulations have yet to be crafted. Passage of the law does not remove the uncertainty about the impact of biosimilars on the market.
We anticipate that a full conference report will be available as soon. Because the issues continue to be so important, however, we are presenting highlights in a blog series in advance of the publication.
Publication now available for download: Mattison, N., Mestre-Ferrandiz, J. and Towse, A. eds (2010) Biosimilars: How much entry and price competition will result? London: Office of Health Economics.
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