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Global Biosimilars: A return to optimism?
Date:12/12/2012

elopment of a biosimilar presents a series of challenges to traditional generic drug manufacturers seeking to enter the sector. To succeed, a company must have good financial backing. Small companies will be able to do the science, but the cost of product development and approval will generally exceed the resources of most chemical generic organisations. After this, there is the cost of marketing and post-market surveillance. There is little prospect in the EU and USA of biosimilars being sold unbranded and biosimilar developers will have to pay for the branding and the marketing of the products; a task for which many lack the funds, sales force and experience.

Corporate manoeuvring is seeing the competitive landscape change
Despite the challenges there has been an upsurge in company activity, most notably from the branded industry and from companies who have no current significant pharmaceutical interests. With the regulatory situation generally favourable to the branded industry, why are they interested?

There are three broad reasons why an originator would wish to become involved with biosimilars. Firstly, it would create a more diversified portfolio, an important consideration in an era of near-dry pipelines. Secondly, it would potentially allow for the development of expertise in the biologic area for companies which traditionally have limited involvement in biologics. Thirdly, it could potentially act as a "spoiler" operation by making the market environment more difficult for smaller biosimilar developers.

Among recent corporate developments
- Pfizer and Biocon announced a deal in October 2010 for the development and worldwide commercialisation of Biocon's recombinant insulin products.
- Boehringer Ingelheim announced the establishment of a separate biosimilar business in September 2011.
- Amgen and Watson announced a deal for the development of biosimilar versions of non-Amgen biologic products in December 2011.'/>"/>
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