US pharmaceutical giant AbbVie has won a key patent dispute over its blockbuster rheumatoid arthritis treatment Humira in the US, dealing a blow to those preparing to commercialize Humira biosimilars in the world’s biggest market for biologic drugs.
Coherus Biosciences Inc. said Tuesday that the US Patent and Trademark Office denied the company’s request for an inter partes review -- the procedure for challenging the validity of a patent via the office -- of AbbVie’s formulation patent on Humira (adalimumab).
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A sign at AbbVie’s headquarters in the US (Yonhap-AP) |
The denial of Coherus’ petition on AbbVie’s Humira patent signals a setback for not only Coherus, but also other firms on track to commercializing a Humira biosimilar in the near future including Amgen, Samsung Bioepis and Momenta Pharmaceuticals.
“This stumble means a significant delay to any future launch of Coherus’ biosimilar” and makes it “unlikely that a Humira biosimilar, even Amgen’s recently approved Amjevita, will be on the market in the U.S. before 2023,” according to Jeffries analysts cited by biotech and pharma news outlet BioPharma DIVE.
Coherus is just one of multiple drugmakers around the world seeking the US launch of a biosimilar referencing Humira, AbbVie’s top-valued drug which generated sales of $14 billion globally last year.
Biosimilars refer to cheaper near-replicas of expensive biologic drugs which have lost patent protection. Drug makers around the world have been developing biosimilars based on blockbuster biologic drugs such as Humira ahead of their patent expiry dates.
AbbVie’s formulation patent on Humira had been set to expire in the US in December 2016 and in Europe in October 2018. However, the firm has been actively filing new patents and lawsuits to defend Humira’s exclusivity in the market and delay the market entry of biosimilars.
In addition to Coherus, major competitors in the Humira biosimilar front include Amgen and South Korea’s Samsung Bioepis, with the former also engaged in a legal dispute over AbbVie’s original drug in the US.
Amgen already secured the US Food and Drug Administration’s approval of Amjevita, a biosimilar referencing Humira, on Sept. 23. Yet, Amjevita’s official launch date remains unclear, as the two firms are currently in a patent infringement suit over the drug in a US district court in Delaware.
South Korea’s Samsung Bioepis, the biosimilars unit of tech giant Samsung Group, is also preparing to launch its Humira biosimilar SB5 in the US, where phase 3 clinical trials for the drug have been completed, according to the FDA’s clinical trials register.
The Samsung unit is expected to seek regulatory approval for SB5 in the US, though the firm has yet to announce when it will do so. Its Humira biosimilar was already accepted for review by the European Medicines Agency in July.
Meanwhile, Nasdaq-listed Momenta Pharmaceutials is currently carrying out phase 3 clinical trials of its own Humira biosimilar M923 in the US. The firm announced in September that it plans to report the topline results of the current phase 3 trial of M923 in late 2016.
By Sohn Ji-young (
jys@heraldcorp.com)
