Evaluate Pharma predict that the six best selling drugs in 2014 will all be biologics. Despite some recent clinical set-backs, Roche’s anticancer drug, Avastin® (bevacizumab), is tipped to be the number one best seller, with 2014 revenues of more than $9 billion. Just behind Avastin® – and rapidly closing the gap – is Abbott’s anti-rheumatic drug, Humira® ( adalimumab). The next four best sellers are predicted to be Rituxan® (rituximab, Roche), Enbrel® (etanercept, Wyeth/Amgen), Lantus® (insulin glargine, Sanofi-Aventis), and Herceptin® (trastuzumab, Roche). Five of these six drugs are antibodies, with three specifically designed to treat cancer.
As the so called patent cliff looms (where many big-selling drugs go off-patent between 2011 and 2013), Evaluate Pharma also predict a large hike in sales of generics. Out of total pharmaceutical sales in 2008 of $643.6 billion, 30% were derived from patented products that are ‘at risk’ from generic competition within 5 years. In 2011, Pfizer’s blockbuster, Lipitor® (atorvastatin calcium) will go generic, together with five further products with annual sales in excess of $4 billion. As a way of maintaining revenues, many large pharma companies are diversifying into the generics market.
Although the patent life of most of the biologics extends well beyond the current patent cliff for small molecule drugs, the present situation highlights the importance of the ongoing debate, particularly in the United States, over a regulatory pathway for biosimilars. The purity and activity of biologics may be more sensitive than those of small molecules to changes in the manufacturing process, leading to concerns that generics may not be equivalent to the original branded drugs.