The Patent Trial and Appeal Board (PTAB), part of the US Patent and Trademark Office, has ruled in favor of biosimilar manufacturer Coherus, striking down one of the patents protecting adalimumab, sold as Humira (adalimumab) by AbbVie.
The compound patent for Humira expired in 2016, but there are a number of other individual patents protecting specific formulations and dosages of the drug. The PTAB’s recent ruling applies to Patent 8,889,135, which “covered subcutaneous dosing of 40 mg of Humira every 13 to 15 days for treatment of rheumatoid arthritis,” according to BioPharma Dive. However, rheumatoid arthritis is not Humira’s only indication, and it makes up just one-third of its total use.
Numerous other patents continue to protect Humira from biosimilar competition. For instance, the PTAB denied Coherus’ petition to review another Humira patent, US 9,114,166, in November 2016. Another Humira patent, 9,085,619, has been challenged through the same “inter partes review” method, and a ruling from the PTAB is likely months away. Any of these rulings can be appealed by AbbVie, according to FiercePharma.
Still, Coherus plans to forge ahead with its adalimumab biosimilar, currently called CHS-1420, by skirting around the remaining patents. It aims to submit an application to the FDA by summer 2017, and hopes to launch the drug in 2018. Shares of the company’s stock had jumped by 8% hours after the board’s decision, while shares of AbbVie dropped by 2%.
“While more remains to be done, this is a significant step forward to lowering drug costs for patients and healthcare providers in the US system,” Coherus president and CEO Denny Lanfear said in a press release. “We believe this successful outcome validates Coherus’ leadership in biosimilar intellectual property and the effectiveness of our platform.”
Amgen’s biosimilar to adalimumab is FDA approved, but Amjevita has not yet hit the market as it is hindered by legal challenges from AbbVie. Sandoz’s adalimumab biosimilar is also progressing through the pipeline, as it recently demonstrated favorable phase 3 results. Sandoz plans to submit an application for GP2017’s approval with the FDA and the European Medicines Agency sometime in 2017.
Humira’s high revenue makes it an appealing target for biosimilar manufacturers. According to one analysis, the average cost of a yearlong course of the drug reached $27,665 in 2015, representing an increase of almost 50% from its cost in 2012. In 2016, it had $16 billion in global sales. The anti-inflammatory drug is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis.