Abstract
Despite the lack of progress in the regulatory situation in the US, the
biosimilars sector is forging ahead as generic companies gain ground in this
high-reward/high-risk business.
The future of the pharmaceutical industry lies with biotechnology. Biotech
drugs account for around 10-15% of the current pharmaceutical market, and the
sector is outperforming the market as a whole in terms of growth.
The issue of the manufacture, approval and marketing of generic biotechnology
drugs has become a major source of debate within the industry for two main
reasons:
1. Cost containment. Biotech products are expensive to develop,
manufacture and administer, and becoming more expensive as newer, more complex
treatments are developed. The availability of generics would spur competition
and hopefully reduce prices.
2. Patent expiry. Patents in the USA and Europe on the older biotech
drugs have either expired or will begin to expire over the next few years.
Manufacturers in Asian, Eastern European and Latin American markets have been
selling biologicals for years. But it is the valuable Western markets that
excite, and a number of new approvals in the EU are raising interest in the
biosimilar sector.
And it' s not just geographical expansion. Dr Reddy' s have launched a
biosimilar version of rituximab for the Indian market, the first monoclonal
antibody to be so produced.
The market may be developing but questions remain:
- Will a significant biosimilar market develop?
- Could an abridged regulatory process really benefit generic manufacturers?
- Which companies are making the moves that are driving change?
- Which therapies are now on the biosimilar radar?
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