- Biosimilar developer Coherus BioSciences said Monday the U.S. Patent Trial and Appeal Board (PTAB) had denied its petition for an inter partes review of a key patent held by AbbVie on the formulation of its mega-blockbuster Humira (adalimumab).
- Coherus is one of many drugmakers developing a biosimilar version of Humira, and its candidate had been considered one of the most significant near-term threats to AbbVie's franchise.
- The PTAB's decision is a win for AbbVie, which relies on Humira sales for more than 60% of its revenue. News of the petition denial buoyed AbbVie stock up about 5% on Monday, while shares in Coherus closed down over 9%.
By avoiding an inter partes review (IPR), AbbVie dodged a major bullet. Humira is AbbVie's biggest selling product, bringing in $2.65 billion in U.S. sales during the third quarter 2016.
AbbVie reported stronger prescription volume and growth across all indications as driving forces behind double-digit sales growth, despite a competitive market. And even with strong growth from the cancer drug Imbruvica, protecting Humira sales will be crucial to propping up revenues in the near-term.
While the PTAB's ruling against Coherus may not be applicable to all Humira biosimilars, according to Evercore analysts "it may be important for Coherus' biosimilar Humira specifically, and today's decision incrementally increases confidence in AbbVie's IP position."
Jefferies analysts believe this stumble means a significant delay to any future launch of Coherus' biosimilar and think it unlikely any Humira biosimilar, even Amgen's recently approved Amjevita, will be on the market in the U.S. before 2023.
Coherus CEO Denny Lanfear noted the company had specifically developed multiple avenues to challenge AbbVie's formulation intellectual property, indicating the arguments used in the IPR petition could also be drawn upon for litigation in district courts.
While the threat from Coherus' biosimilar appears blunted for now, other challengers are on the horizon. Amgen's Amjevita, for example, has a court date set for late 2019 to settle IP issues between the two companies.
Others are likely to follow, including Momenta's version, currently in Phase 3, and a candidate in development by Merck & Co. and partner Samsung Bioepis.