Although small molecule drugs still dominate the global pharmaceutical market in terms of numbers, biologicals are making a significant dent. However, the high cost of biologicals is putting increasing pressure on healthcare budgets, thus opening the door to biosimilars. With patents on originator biologicals expiring, biosimilars are expected to take an increasing share of the biologicals market. In light of these facts, this paper gives estimated patent expiry dates for some of the best-selling biologicals.
Biosimilars are now a reality. The European Medicines Agency (EMA) approved its fi rst biosimilar Omnitrope (somatropin) back in 2006 [1]. Since then, EMA has approved more than 20 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythtropoesis stimulating agent, insulin and tumour necrosis factor (TNF)-inhibitor, for use in the European Union (EU). Many blockbuster biologicals have already or will soon face competition from biosimilars due to patent expiries and loss of exclusivity. There are also more than 200 new biotechnology
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