Amgen filed a biosimilar application for AbbVie’s Humira® (adalimumab) on November 25, 2015. The application represents a number of firsts: it is Amgen’s first application under the 351(k) licensure program of the Biologics Price Competition and Innovation Act (BPCIA), it is the first biosimilar application for Humira®, and it is the first biosimilar application for a monoclonal antibody. Humira®, a monoclonal antibody against TNF-alpha, is the world’s best-selling prescription drug, bringing in $6.5 billion in U.S. sales in 2014, with another $6 billion outside the U.S. The drug is approved in over 90 countries for multiple indications. In the U.S. it is approved for nine indications, including rheumatoid arthritis, chronic plaque psoriasis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. Humira® is used for pain relief and to reduce inflammation in a number of autoimmune diseases. Amgen’s application for its biosimilar, ABP 501, included analytical, clinical, and pharmacokinetic data.1
Phase 3 clinical trials of the drug for use treating rheumatoid arthritis and plaque psoriasis patients showed comparable efficacy and safety to its reference biologic Humira®. As the application includes “[d]ata to support the transition of adalimumab patients to ABP 501 are included in the submission,” this submission may also be the first application for an interchangeable biologic product.
The biosimilar market will only continue to heat up in the future. This filing also reflects that, unlike the small molecule market where companies are either branded or generic, the biosimilar market will find companies with the required expertise on both sides of the fence. While this is Amgen’s first biosimilar application, it has seen three biosimilar applications filed to date against its own products by Sandoz. Sandoz’s application for Zarxio® (filgrastim biosimilar), which used Amgen’s Neupogen® as a reference product, was approved in March 2015 as the first biosimilar under the BPCIA’s 351(k) licensure program and launched in the U.S. in September 2015. Sandoz also filed applications for biosimilars of pegfilgrstim and etanercept using Amgen’s Neulasta® and Enbrel® as reference products, respectively. Amgen itself has two other biosimilar molecules in pivotal Phase 3 trials and three in other stages of development. 2
Currently, all eyes are on the Supreme Court as market players wait to see if the patent information exchange provisions of the BPCIA (the “patent dance”) are mandatory. Such provisions are intended to facilitate litigation over patent rights covering the reference product. Sandoz failed to comply with these provisions after approval of Zarxio®, asserting that the provisions were not mandatory. This position was supported by the Court of Appeals for the Federal Circuit, though the Court held that the 180 day commercial notice could not be made until the biosimilar application was granted.3
One or both of Amgen and Sandoz are expected to file for certiorari
to the Supreme Court (petitions due January 14, 2016). 1 http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-newsArticle&ID=2118315 2 http://www.amgenbiosimilars.com/our-products/our-pipeline/ 3 Amgen, Inc. v. Sandoz, Inc.
, 794 F.3d 1347 (Fed. Cir. 2015), rehearing en banc
denied Oct. 16, 2015. Download PDF