EP Vantage 2016 Preview (III): Drugs off patent and Companies Risk

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Like drug launches, patent expiries are a natural part of the lifecycle of the healthcare industry, and in 2016 some companies are going to be hit harder than others. 

Humira may be 2016’s best-selling drug, but how long it will retain this top ranking is wide open to debate. The drug technically loses a key US patent in December 2016, and biosimilar makers are already circling. Merck & Co and Pfizer both have phase III versions of the arthritis MAb in development, and last month Amgen submitted its Humira lookalike, ABP 501, to the FDA. 

That said, the biosimilar pathway in the US has not been entirely cleared of debris, giving Rick Gonzalez, AbbVie’s chief executive, the confidence to be adamant about keeping biosimilar competition in the US at bay until at least 2022. The fact that Humira makes up 62% of AbbVie’s sales must provide extra motivation for keeping biosimilars off the market for as long as possible.

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Patent expiries for Astra’s Crestor and Glaxo’s Seretide/Advair put them firmly in the top five companies by patent risk in 2016, while the loss of three drugs, including the cholesterol lowerer Zetia, gives Merck & Co its entry in the chart. 

Once again the cash cow Humira is AbbVie’s greatest strength and its greatest weakness, but there is little likelihood of a challenger being launched in the US in 2016. 

Like AbbVie, the massive erosion of both J&J’s and Roche’s sales by 2018 and 2020 respectively will come from the US biosimilar threat to some of their biggest names. For J&J it is the 2018 patent expiry of Remicade, while Roche’s Avastin, Herceptin and Rituxan are all set to lose patent protection by the middle of 2019. Roche is, however, already starting the lifecycle management fightback with a variety of strategies that include developing its own second generation of products with better efficacy and working on formulations to make administration easier or more convenient. (Más)

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EP Vantage 2016 Preview (II): Biggest Launches 2016