Biosimilars and Biobetters: Positioning for a New Market-Aarkstore Enterprise

April 8, 2010 - PRLog -- Patents on the earliest approved biologics, including many blockbusters with over $1 billion in annual sales, have started to expire. This has opened the market to biosimilar competition, initially in the EU, where a total of 12 biosimilar products have now been aproved. In the US a few follow-on-biologics (FOBs) of products regulated under NDAs have been approved, but there is no abbreviated approval pathway for biologics regulated under BLAs (which are the majority). However, biosimilar legislation is now under intensified consideration.

In preparing this Report, we reviewed the portfolios of almost 500 innovator companies. We analyze all the major classes of innovator biologicals on the market and in development; some launched innovator products are already, or will soon be targets for biosimilars, while other launched products and pipeline products represent potential competition. These products include improved biologicals ("biobetters") with specific enhanced characteristics. The technologies used to produce biobetters, reviewed in this Report, focus on drug delivery, half-life extension, glycoengineering, and cell production systems.


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