New Humira Formulation May Extend Patent Life of Blockbuster

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Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?


The market for AbbVie’s Humira (adalimumab) has remained stable in the US in 2015, according to a recent Q2 AbbVie call, despite a biosimilar version of infliximab hitting the market overseas. The company believes a new formulation of the drug could help differentiate the product and drive the company’s future commercial strategy.

Global sales on Humira increased approximately 8%, but international sales growth in the second quarter fell 14%, a decline managers attributed to shipment timing problems, not to biosimilar competition. In fact, projected EvaluatePharma data on Humira net sales place the drug as the number one top-seller in 2020; the medication is expected to rake in about $8 billion in 2020, which is $1.5 billion more in 2020 than in 2014.

When discussing AbbVie’s biosimilar strategy in the call, CEO Richard Gonzalez pointed to the company’s portfolio of intellectual property, some of which he said “is very broad and very challenging, I think, for someone to work around."


AbbVie recently received approval from the EMA for a new formulation for Humira, which is specifically designed to reduce injection pain, injection volume, and potentially the number of injections required. The formulation is currently under review by FDA. A part of the commercial strategy surrounding the new formulation could be to switch patients to a new formulation of Humira before a biosimilar version of the drug is released in the US market, much like Teva did when it released a new formulation of Copaxone (glatiramer acetate) prior to the approval of Sandoz/Momenta’s Glatopa. The improved Copaxone formulation, which gave the drug a renewed patent life, was heavily marketed to patients prescribed the older formulation of the drug. Teva estimated in April 2015 that nearly 70% of users switched to the new formulation, staving off much of the market competition from Glatopa, at least in the short term.

The US release of a new formulation of Humira is not without its challenges, however. In June 2015, Amgen filed an intellectual property rights suit against AbbVie's 8,916,157 patent, which claims an innovative formulation for Humira, according to an investor note from Evercore ISI.