US PTO Denies Review of Formulation Patent for Biosimilar of AbbVie’s Humira

Coherus BioSciences, headquartered in Redwood City, California and focused on biosimilar therapeutics, has received a decision from the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office denying Coherus’ petition for Inter Partes Review of a formulation patent for AbbVie’s Humira (adalimumab) , the company’s top-selling drug with 2015 sales of $14 billion. 

The patent, US Patent 9,114,166, related to formulation of human antibodies for treating TNF-alfa associated disorders. Humira is an anti-TNF-α monoclonal antibody approved in for the treatment of several inflammatory diseases.

Humira was first approved by the US Food and Drug Administration in December 2002 and is indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, pediatric Chrohn’s disease, and ulcerative colitis.

Coherus has targeted regulatory filing for its Humira biosimilar, designated CHS-1420, for the fourth quarter of 2016 or first quarter of 2017 in the US and for 2017 in the European Union, according to the company.

Source: Coherus BioSciences

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