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. (http://www.bharatbook.com/
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;
A comprehensive analysis of the market has led us to conclude that biosimilars, presently worth just $75 million worldwide, could generate a global market of $5.6 billion (7% of all biosimilar-susceptible biologic sales) by 2013. Current sales are constrained by the lack of a streamlined regulatory pathway for biosimilars in the US, which is the world's largest market for biologics, and conservatism among prescribers. In the short term, the latter issue can be addressed by quotas and other incentives. In the longer term, improvements to biosimilar products would help to differentiate competing products in an increasingly crowded market.
A vast array of peptide, protein and other biosimilar targets are examined in detail in this Report. Peptides reviewed include glatiramer and other high-selling products such as somatostatins and LHRH analogs; proteins include insulins, growth hormone, Il-2, interferons, G-CSF, GM-CSF, enzymes, erythropoietins, coagulation factors and plasminogen activators; other biologicals include enoxaparin, vaccines, and botulinum toxins.
Monoclonal antibodies (mAbs), which represent some of the largest selling biotechnology products, are reviewed separately. Efforts to improve mAbs are aimed at improving effector funtions or at extending the serum half-life. Blockbuster established mAbs include TNF-targeting etanercept and infliximab and tumor cell antigen-targeting rituximab.
The Report also profiles 40 biosimilar companies, highlighting their characteristics, biosimilar portfolios and collaborations. Overall, the picture that is emerging is of short-term strategies to compete on price with first-generation biosimilars and longer-term strategies to dominate the market with improved (biobetter) biosimilars. Significantly, at least half of the western biosimilar companies surveyed have developed or acquired proprietary technologies for producing improved biologics
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