Biosimilars can be defined as biotech drugs that have been shown to have comparable quality, safety, and efficacy to the original
product. Scientific and regulatory issues around approval of biosimilars have been a topic of great interest and debate lately
in Europe and in the United States. A key concren is industry's limited understanding of how the different quality attributes
(QA) of a biotech product affect its safety and efficacy. India is globally regarded to have great potential to become a significant
player in the development and commercialization of biosimilars. This article, the 25th in the "Elements of Biopharmaceutical
Production" series, aims to present the current status of India in this context, the challenges that need to be overcome,
and some recommendations that may alleviate these challenges.
Anurag S. Rathore
GLOBAL SALES PROJECTION FOR BIOSIMILARS
Patents of many top-selling biopharmaceuticals are set to expire (see Figure 1) (1). Expiries will begin in 2012 with the
Enbrel (Amgen/Pfizer) patent and continue through 2017. The peak will occur in 2015 when four products—Neulasta (Amgen),
Herceptin (Roche), Lantus (Sanofi-Aventis), and Rituxan/MabThera (Roche)—face patent expiration. Sales of biosimilars will
be primarily driven by sales in the developed countries (i.e., US and Europe) with the US constituting approximately 90% of
the global market.
Elements of Biopharmaceutical Production
A regulatory pathway for approving bisimilars is already in place in Europe—14 such products have been approved to date (1).
The pathway in the US, although approved under the Biologics Price Competition and Innovation Act of 2009, is still being
implemented. In Japan, although a regulatory guidance for biosimilar approval was issued in 2009, the slow adoption of small-molecule
generic drugs suggests that the approval of biosimilars is likely to begin later than in the US.
Figure 1: Upcoming patent expirations of 10 top-selling biopharmaceutical products (Data, Ref. 1). (ALL FIGURES ARE COURTESY
OF THE AUTHOR)
THE ECONOMICS OF BIOSIMILARS
Although the financial drivers for growth of biosimilars are widely recognized to be significant, there are some key aspects
that distinguish biosimilars from the small-molecule generic drug market. Performance of biosimilars in Germany, the largest
biosimilar market at present, shows that the substitution rate for biosimilar epoteins is about 35% of the total sales of
epoetin. This percentage is quite different from the >90% rates that are commonly achieved for small-molecule generics (2).
This difference is partly due to the observation that patients taking biotech therapeutics show an aversion towards switching
to the corresponding biosimilars (3).
PHOTO CREDIT: MARTIN CHILD, GETTY IMAGES
Development and commercialization of a biosimilar requires anywhere from $10–40 million compared with the $1–2 million typicaly
required for a conventional small-molecule generic drug. Furthermore, biosimilars are expected to be priced at only a 20–25%
discount in comparison with their original products, a significantly smaller discount than what is common with small-molecule
Overall, the effect on overall drug pricing will be much more limited with biosimilars than with small-molecule generics.
Patient behavior is also likely to result in slower adoption.