- The U.S. Patent Office will review an important patent for AbbVie's blockbuster anti-inflammatory drug Humira, accepting a petition from Coherus BioSciences, the company said Tuesday.
- Coherus hopes to bring a biosimilar version of Humira to market in the U.S. and challenged AbbVie's patent on a bi-weekly dosing regimen for the drug.
- Markets reacted sharply to the news, sending AbbVie stock down 3.5% and boosting Coherus by nearly 17%. But although Coherus' challenge was accepted for review, a trial will still need to be held and a final decision may not come for a year, as Bloomberg notes.
Humira continued its reign at the top of the global drug market last year, raking in over $14 billion in sales - an 18% jump compared to 2014. Investors are concerned competition from biosimilars could deal a major blow to revenue from Humira, which accounted for 61% of total net revenues in 2015.
Already, Amgen has filed an application to market its biosimilar copy of Humira, called ABP501. A target action date is set for September 25, 2016, but the drug has been delayed before. Merck is also developing its own copy of Humira, pushing into Phase 3 trials last month.
AbbVie's composoition of matter patents on Humira will expire in December of this year, but AbbVie CEO Rick Gonzalez believes the company can stave off biosimilar compeititon until 2022, according to EP Vantage. Non-composition of matter patents don't expire until 2022 in the U.S.
Coherus challenged one of these non-composition of matter patents, which protects AbbVie's dosing regimen for Humira in rheumatoid arthritis, through a procedure known as inter partes review (IPR). IPR allows companies to challenge a patent without taking the patent holder to federal court.
"We welcome this PTAB [Patent Trial and Appeal Board] decision, and are confident that this will lead to a final decision nullifying the ‘135 Patent, ” said Denny Lanfear, CEO of Coherus.
Coherus has also filed petitions with the Patent Office on three other patents.