- Amgen has filed suit to enforce its patent rights on Enbrel (etenercept), claiming Sandoz's regulatory submission to the FDA for a biosimilar version infringes on its patent, FiercePharma reports. The FDA accepted Sandoz's application in October 2015.
- Amgen is seeking an injunction against Sandoz, the generics unit of Novartis, because it says Sandoz is benefiting from the work Amgen did to develop the market for Enbrel, including numerous clinical studies.
- Although Sandoz is seeking approval for numerous indications, the company has only conducted two large studies on its biosimilar version of Enbrel—a pharmacokinetic study in healthy volunteers and a safety and efficacy study in patients with plague psoriasis.
When Sandoz submitted its application to the FDA for approval of biosimilar Enbrel, it used the new 351(k) pathway. While the guidance surrounding biosimilar applications is still in flux, indication extrapolation has been accepted as a norm despite some controversy.
Since Sandoz proved biosimilarity in its submission package, the company contends that it has the right to move forward with its application for all indications of the originator product.
Enbrel was approved in 1993 and is indicated for treatment of moderate-to-severe rheumatoid arthritis, moderate-to-severe plague psoriasis, juvenile idiopathic arthritis and ankylosing spondylitis. The drug grossed close to $5 billion last year.
Sandoz has pushed forward forcefully in the biosimilar market. Not only did it gain approval for the first biosimilar in the U.S. last year (Zarxio), but it also has several other biosimilars in development, including a version of AbbVie's Humira.