- A key panel of the U.S. Patent and Trademark Office invalidated one of AbbVie's numerous patents protecting its top-selling Humira (adalimumab), ruling in favor of biosimilar maker Coherus Biosciences' challenge.
- The ruling was widely expected by analysts, and AbbVie's broad intellectual property covering Humira's dosing will likely prevent market launch of a competing biosimilar for several years yet. Even so, shares in Coherus rose by as much as 8% Wednesday morning on the news. AbbVie shares fell by more than 2%.
- One biosimilar of Humira, Amgen's Amjevita (adalimumab-atto), has already been approved in the U.S. But Amgen and AbbVie are currently tied up in patent litigation, with a trial set for late 2019 — lessening the likelihood Amgen would decide to launch "at risk" in the near-term.
As one of the best-selling drugs in the world, Humira is a ripe target for biosimilar makers hoping to steal away some of AbbVie's share of the anti-TNF market.
Sales of the drug totaled $16.1 billion last year, with $10.4 billion in the U.S. alone. And despite being an older, established biologic, Humira continues to notch impressive growth in the U.S. — sales jumped 23% in the first quarter on higher prescription volume.
Although Humira's compound patent expired in December 2016, AbbVie has a wide array of other patents covering formulations and dosing of the drug. Company CEO Richard Gonzalez expects AbbVie's IP position will stave off any competition from lower-cost copycats until 2022.
But companies like Coherus are beginning to chip away at those defenses. The Patent Trial and Appeal Board (PTAB) now has invalidated all claims tied to AbbVie's U.S. Patent 8,889,135 (commonly referred to as the '135 patent), which covered subcutaneous dosing of 40 mg of Humira every 13 to 15 days for treatment of rheumatoid arthritis.
"We are disappointed by the ruling from the PTAB," AbbVie said in an emailed statement. "Humira represents true innovation in the field of biologics and is protected by a vast portfolio of intellectual property. We intend to appeal this decision."
Other so-called inter partes review challenges filed by Coherus had been previously rejected by the PTAB, giving AbbVie some breathing room. Coherus, though, is developing alternative formulations to sidestep those patents which have been upheld, and plans to file a Biologics License Application for its Humira biosimilar with the Food and Drug Administration by the end of this quarter.
Coherus has said it hopes to launch in 2018, and has filed four other petitions for inter partes review of another one of AbbVie's patents. A decision on those challenges is expected in the third quarter.
Analysts noted, though, that other patents will likely make it difficult for Coherus or fellow biosimilar makers to launch before 2021, while the legal back-and-forth could tie up Amjevita from making it to market before then.
"We did not view the ‘135 patent as critical to the delay of US biosimilars given the extensive IP portfolio behind Humira," wrote Jeffery Holford, an equity analysts with Jefferies, in a note to investors. "Therefore, we believe that a 2% 'sentiment hit' to the shares at the most is appropriate, due to the lost optionality of a win."