Amgen’s Amjevita approved by the FDA as the first biosimilar to blockbuster Humira.
By Manoli Kavishwar, Analyst
28 September 2016
I am an analyst at Datamonitor Healthcare, based in the London office, where I am a member of the Immunology and Inflamm...
Read full bio
On 23 September 2016, Amgen and Daiichi Sankyo’s Amjevita/ABP 501 (adalimumab-atto) was approved by the US Food and Drug Administration (FDA), marking the entry of the first biosimilar referencing blockbuster Humira (adalimumab; AbbVie/Eisai) to the US market (FDA, 2016). While initial uptake of the biosimilar is expected to be slow and weighted towards new patients due to physician caution and brand awareness, Datamonitor Healthcare anticipates Amjevita and other adalimumab biosimilars to substantially erode Humira’s market share in the longer-term, driven by differences in pricing and the increasing availability of post-marketing safety data.
Amjevita was approved for seven of Humira’s indications, covering inflammatory bowel disease, arthritic and dermatologic diseases, but excluding four indications including pediatric Crohn’s disease and uveitis, which are still protected by orphan drug exclusivity (FDA, 2016). The approval followed unanimous endorsement from the FDA Arthritis Advisory Committee in July 2016, with the panel concluding that the totality of the evidence supported approval of the product for Humira’s indications (Spondylitis Association of America, 2016). Amjevita presented a comprehensive data package to the Arthritis Advisory Committee to support its biosimilarity to Humira, demonstrating equivalent efficacy to Humira in two Phase III clinical trials involving patients with moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, with approval for all other indications reliant on analytical similarity (Amgen, 2016).
However, despite the FDA approval, it remains unclear when Amjevita will be launched in the US market, with any launch dependent upon successful litigation relating to multiple patents held by AbbVie for Humira. With Humira responsible for more than 60% of AbbVie’s global annual revenue in 2015 and global sales of the drug having increased by 17.4% in Q2 2016, driven by continued momentum in rheumatology, dermatology, and gastroenterology markets, AbbVie is heavily invested in protecting Humira from biosimilar competition (AbbVie, 2015; AbbVie, 2016).
AbbVie, which has a number of late-expiring patents for Humira, has stated that its legal protection will keep Humira safe from biosimilar competition until 2022 (American Pharmacists Association, 2016). On 4 August 2016, AbbVie filed a patent infringement suit against Amgen in the US District Court, claiming that the biosimilar infringes 61 of the more than 100 patents that cover Humira, and threatened a second wave of litigation involving dozens of additional patents if Amgen attempted to start the process for commercial marketing of its biosimilar (Scrip, 2016a).
With a scheduling conference set to be held in the US District Court on 27 October 2016, should the litigation proceed, the timeline for the litigation process would typically be expected to take around four years from 351(k) filing, giving a first biosimilar launch in the US in November 2019, which allows for launch being delayed by appeal, with any faster resolution of litigation bringing this date forward. However, in the event that Amgen is able to successfully overturn the patents on Humira, Amjevita is expected to launch in the US in Q1 2017 due to a July 2015 ruling from the US Court of Appeals involving the Biologics Price Competition and Innovation Act, which states that biosimilar sponsors must wait 180 days after gaining approval before marketing the drug (Scrip, 2016b).
Datamonitor Healthcare anticipates initial biosimilar uptake to be slow, with key opinion leaders stressing that prescribing is expected to be initially weighted towards new patients and driven by differences in pricing.
“We have guidance… that we usually adhere to, stating that if a patient is doing well on a particular treatment we do not change it, even if that is a biosimilar… so it [the biosimilar] will be mostly prescribed to new patients… in the beginning.”
Anonymous key opinion leader
However, with drug costs a major influence on prescribing trends, Datamonitor Healthcare expects Humira to lose significant patient share to the cheaper biosimilar as more long-term efficacy and safety data become available for Amjevita, with patients receiving the brand increasingly being switched to the biosimilar version.
“There will be some drive by other forces, especially by hospitals and hospital pharmacists that have better deals with biosimilar companies.”
Anonymous key opinion leader
AbbVie (2015) Financial Release: AbbVie Reports Full-Year 2015 and Fourth-Quarter Financial Results. Available from: http://www.abbvieinvestor.com/phoenix.zhtml?c=251551&p=irol-newsArticle&ID=2133541 [Accessed 26 September 2016].
AbbVie (2016) Financial Release: AbbVie Reports Second-Quarter 2016 Financial Results. Available from: http://www.abbvieinvestor.com/phoenix.zhtml?c=251551&p=irol-newsArticle&ID=2190030 [Accessed 26 September 2016].
American Pharmacists Association (2016) U.S. patent office rules against Amgen adalimumab challenge. Available from: https://pharmacist.com/us-patent-office-rules-against-amgen-adalimumab-challenge [Accessed 26 September 2016].
Amgen (2016) Amgen to Discuss Data Supporting Biologics License Application for ABP 501, A Biosimilar Candidate to Adalimumab. Available from: http://wwwext.amgen.com/media/news-releases/2016/07/amgen-to-discuss-data-supporting-biologics-license-application-for-abp-501-a-biosimilar-candidate-to-adalimumab/ [Accessed 26 September 2016].
FDA (2016) FDA Approves Amjevita, a biosimilar to Humira. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm [Accessed 26 September 2016].
Scrip (2016a) AbbVie v. Amgen Round One: Humira Biosimilar Infringes 10 Patents, Suit Claims. Available from: https://pink.pharmamedtechbi.com/PS118913/AbbVie-v-Amgen-Round-One-Humira-Biosimilar-Infringes-10-Patents-Suit-Claims [Accessed 26 September 2016].
Scrip (2016b) Innovators Employ Labyrinthine Defenses To Fend Off Biosimilars. Available from: https://scrip.pharmamedtechbi.com/SC097142/Innovators-Employ-Labyrinthine-Defenses-To-Fend-Off-Biosimilars [Accessed 26 September 2016].
Spondylitis Association of America (2016) FDA Advisory Committee Unanimously Recommends Approval of a Biosimilar Version of Humira (Adalimumab) for Ankylosing Spondylitis, Psoriatic Arthritis, and More. Available from: https://www.spondylitis.org/About-SAA/News/fda-unanimously-recommends-biosimilar-humira-adalimumab [Accessed 26 September 2016].
Get your free demo of Datamonitor Healthcare today. Simply fill out the form to the right >>>