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The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.
The US Patent and Trademark office released a statement on Jan. 14, 2016 denying Amgen’s petition to review two formulation patents for AbbVie’s Humira (adalimumab). Adalimumab is a biologic medication developed by AbbVie that is indicated for treatment of patients with rheumatoid arthritis (RA). The company currently has 70 patents protecting adalimumab with annual sales at an estimated $14 billion. In the past, the company has stated they plan on aggressively defending the patents, which they expect will protect the drug from competitors, until 2022.
Amgen challenges multiple claims on Humira’s ‘157 patent, which focuses specifically on the antibody formulations of the drug. In the decision, the US Patent Office stated, “we find that Amgen has not established a reasonable likelihood of prevailing with respect to at least one challenged claim of the ‘157 patent.”
The US Patent Office’s denial of the request marks a setback for Amgen, who plans to have their first biosimilar on the market between 2017 and 2019. Amgen’s biosimilar, ABP 501, is the first biosimilar submitted to FDA for Humira. According to a report by Reuters, the company says they still plan to challenge the legality of AbbVie’s patents.
In an investor report sent on Jan. 14, 2016, Mark Schoenebaum, PhD, senior managing director of Evercore ISI's Health Care Research Team, remarks that because biosimilars do not have to have the same formulation as reference products, companies have the ability to design around formulation patents. However, he says, while these patents may not be important for all Humira biosimilars, they may be relevant for Amgen’s biosimilar.
Source: Reuters, The United States Patent and Trademark Office