Coherus BioSciences announced that the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office ruled in the company's favour in a challenge over AbbVie's Humira (adalimumab) by invalidating all claims of a patent covering the drug. Denny Lanfear, CEO of Coherus, which has been seeking to launch its proposed Humira biosimilar CHS-1420, said "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."
Specifically, Coherus explained that the claims of the so-called '135 patent were directed to a method for treating rheumatoid arthritis by administering Humira subcutaneously every 13 days to 15 days. "We will continue to aggressively press forward with the development and commercialisation of our CHS-1420 [Humira] biosimilar," remarked Lanfear.
Meanwhile, AbbVie stated it was "disappointed" by the PTAB decision, adding that it intends to appeal the ruling. Last month, the company reported that sales of Humira in the first quarter climbed by 15.1 percent to $4.1 billion. The therapy accounted for 63 percent of AbbVie's revenue in 2016.
Leerink analysts recently suggested that "the hurdle for any biosimilar company to launch a biosimilar Humira by 2019 is still high, and given AbbVie's extensive patent estate extending into the 2030's, any biosimilar challenger must be willing to undertake an at-risk launch until further patents are invalidated through the [inter partes review] process or the federal circuit courts."
However, the analysts noted that "removing the dosing patent opens the door for a fast-to-market approach with biosimilar formulations that do not infringe AbbVie's 14-plus formulation patents, of which Coherus has publicly disclosed development." Leerink analysts added that "the strategies of these challengers…still have significant impact on the legitimacy of Coherus' programme, but we expect the market to price in a worst-case 2019E biosimilar launch after this '135 decision."
Citi analyst Andrew Baum explained that a ruling in favour of AbbVie, whose shares declined as much as 4 percent on news of the PTAB decision, "would have likely translated into a material re-rating of the stock to reflect a timing of biosimilar entry in mid-2020s rather than our 2020 base case." The analyst noted that in the meantime, shares in the drugmaker are "likely range bound until resolution of ongoing Humira legal cases."
In November, the US patent board denied institution of Coherus' petition challenging AbbVie's so-called '166 patent related to the formulation of Humira. Meanwhile, last September, the FDA approved Amgen's Humira biosimilar Amjevita (adalimumab-atto) for multiple inflammatory diseases. Prior to the FDA's decision, AbbVie had filed a patent infringement lawsuit in the US seeking to block Amgen from marketing its biosimilar product, and the case remains pending. Amgen has indicated that it was unlikely to launch Amjevita in the year following its approval due to the pace of litigation. The European Commission also recently approved Amjevita for the treatment of certain inflammatory diseases.
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