Biomedical Engineering Reference
In-Depth Information
The discussion on pharmaceutical lifecycle extension strategies in this chapter
has focused on nonbiologic drugs. These differ substantially from biologics due to
their complexity, which makes biologics more expensive and it is harder to produce
therapeutically equivalent generic versions of them. However, the number of
approved biologics is rising substantially and their share of pharmaceutical sales is
increasing (Munos
2009
). Regulations on the approval of biologics that are biosimi-
lar to drugs already on the market, is not well established yet and little research
exists on their impact. In 2005, the EMA has published guidelines for biosimilars
that give product-specifi c guidelines for their approval. In 2009, US congress has
passed the Biologics Price Competition and Innovation (BPCI) Act, allowing the
FDA to approve biosimilars. The FDA is currently working on guidelines for an
approval path for biosimilars (Kozlowski et al.
2011
). The guidelines will be stricter
than the approval of generic nonbiologics. However, when the patent on a biologic
expires, biosimilars will enter if the market is attractive enough. Compared to non-
biologics, production and entry costs of biosimilars are higher, limiting the number
of generic entrants. Hence, in the future biologics are still likely to face less compe-
tition after patent expiry, making them an attractive alternative to nonbiologics and
a very important topic for research.
Most strategies to extend the lifecycle involve interdisciplinary knowledge on
marketing, R&D and regulations. This makes it challenging to investigate various
lifecycle extension strategies in-depth. The marketing and economics literature
have largely overlooked the impact of R&D and legal strategies. Plenty of research
exists on the technical issues around R&D strategies and the legal issues surround-
ing the regulations and law on drugs, but is not discussed in detail here. Research on
pharmaceutical lifecycle extension strategies would benefi t from researchers or
interdisciplinary research teams that are able to jointly assess the impact of market-
ing, R&D, and legal strategies. Finally, research on pharmaceutical lifecycle exten-
sions would benefi t tremendously from a study comparing the impact of the various
strategies. One way to do that is to collect information on the various strategies and
some moderators and relate those to the stock returns of pharmaceutical fi rms.
References
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Ashburn TT, Thor KB (2004) Drug repositioning: identifying and developing new uses for existing
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Bae JP (1997) Drug patent expirations and the speed of generic entry. Health Serv Res 32(1):87-101
Berndt ER, Kyle MK, Ling DC (2003) The long shadow of patent expiration. Generic entry and
Rx-to-OTC switches. In: Feenstra RC, Shapiro MD (eds) Scanner data and price indexes.
University of Chicago Press, Chicago, IL, pp 229-273
Berndt ER, Mortimer R, Bhattacharjya A, Parece A, Tuttle E (2007) Authorized generic drugs,
price competition, and consumers' welfare. Health Aff 26(3):790-799
Bhat VN (2005) Patent term extension strategies in the pharmaceutical industry. Pharm Policy Law
6:109-122
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