Recently, Abbott Laboratories broke itself up into two parts: Abbott, a diversified medical products company and AbbVie, a research based pharmaceutical company. The jewel of the new pharma company is Humira, an antibody that blocks a mediator known as TNF-alpha and is an important treatment for rheumatoid arthritis (RA) as well as other immunological disorders. It is also now the world’s top selling drug with 2012 sales estimated to be in excess of $9 billion.But Humira is not just a small jewel for AbbVie – it’s the Hope diamond. This was spelled out in a FirstWord Pharma article entitled: “Spotlight on: On the back of 4Q results, AbbVie and Novartis demonstrate contrasting routes towards growth. In a stunning graph, it projected that in 2016, 60% of AbbVie’s revenues will be coming solely from Humira sales. This is in contrast to the rest of the industry, where it is rare that a company generates as much as 20% of its sales from one product. Theoretically, this should be a cause for alarm. Based on Abbott’s “Information Statement” filed with the Securities and Exchange Commission, the US composition of matter patent for Humira is expected to expire in December 2016 and in the majority of Europe by April 2018. Ordinarily, this is a major problem as sales drop precipitously once a product has generic competition. However, Humira is a biological product and generic versions of biologics like antibodies have been slow to market due to difficulties in manufacturing exact copies of the drug. (This contrasts with the situation with traditional small molecule drugs where chemical synthetic processes are straightforward in manufacturing.) However, this situation is changing. The Biologics Price Competition and Innovation Act, passed on 3/23/10 as part of the Affordable Care Act, creates a framework for the approval of generic versions of biologics (called “biosimilars”). A similar framework already exists in Europe. Furthermore, there are novel new RA drugs being approved, such as Pfizer’s Xaljenz, that will be competitors to Humira. Given this scenario, it is hard to imagine that by 2017, Humira will be a source of revenue growth for AbbVie. In fact, it is entirely possible that sales will be eroding significantly.
