Coherus Fails in Challenge of Humira Patent, AbbVie Releases Phase 3 Results for New RA Drug

Coherus BioSciences announced last week that its petition for inter partes review (IPR) of AbbVie’s US Patent 9,085,619 (the ‘619 patent), covering the formulation of adalimumab (Humira), was not instituted by the Patent Trial and Appeal Board (PTAB).

In January, Coherus filed 4 petitions challenging the ‘619 patent, saying that the ability of proteins to self-buffer has been known for decades, and therefore the ‘619 patent should not have been issued.

In a filing with the US Securities and Exchange Commission on Thursday, Coherus indicated that, should the PTAB issue a final written decision that upheld the the ‘619 patent claims, Coherus would not be able to use its arguments against the patent in district court proceedings. However, if other biosimilar developers successfully challenge the ‘619 patent in the future, Coherus could benefit from the patent’s being found unenforceable.

Coherus’ setback is not just bad news for the California-based biosimilar developer; PTAB’s decisions could further delay the product launches of the 2 currently FDA-approved adalimumab biosimilars. Amgen’s Amgevita (adalimumab-atto) was approved in 2016, and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) was approved last month. Neither drug is expected to launch prior to 2018.

AbbVie’s win in this IPR petition allows the drug maker additional time to develop its new rheumatoid arthritis (RA) drug, the JAK1 inhibitor upadacitinib, which could help AbbVie retain its hold on the lucrative RA marketplace even after adalimumab biosimilars reach patients. Today, AbbVie announced that its investigational drug had met all primary and ranked secondary endpoints in its second phase 3 RA study. The SELECT-BEYOND trial showed that, after 12 weeks of treatment, once-daily doses of both 15-mg and 30-mg of upadacitinib met the study’s primary endpoint of producing ACR20 (or the American College of Rheumatology 20% improvement in tender and swollen joint counts; patient assessments of pain, global disease activity, and physical function; physician global assessment of disease activity; and acute phase reactant) and low disease activity.

“We are very pleased with the positive results for upadacitinib in the SELECT-BEYOND trial. Particularly exciting is the proportion of patients who achieved clinical remission by week 12 and 24, despite having inadequate responses with previous biologic therapies,” said Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie. “Together with previously reported results from SELECT-NEXT, these data further support the potential for upadacitinib to be a meaningful treatment option for [RA] patients. We continue to build upon our leadership in immunology as we advance the development program for upadacitinib across a broad range of immune-mediated diseases.”

Excitement about upadacitinib is tempered by the fact that the FDA issued a complete response letter for a similar JAK1 inhibitor, baricitinib, in April, citing the need for further data to demonstrate the product’s safety in light of an imbalance between thromboembolic events in the treatment arm versus the placebo arm during the product's RA clinical program. In the European Union, where baracitinib has been approved, the product’s description lists adverse reactions includes nausea, infections, lipid elevations, neutropenia, and thrombocytosis. JAK1 inhibitors as a class came under intense scrutiny after phamracovigilance data from the first drug in the class, tofacitinib (Xeljanz) revealed 18 primary cases of pulmonary embolism in patients taking the drug.