Summary: Amjevita is an FDA-approved biosimilar version of adalimumab (reference product, Humira®, Abbvie).
Originally known as ABP 501, Amgen submitted a biologic license application for approval via the 351(k) biosimilar pathway in November 2015. The Food and Drug Administration (FDA) approved the biosimilar in September 23, 2016. The European Medicines Agency approved Amjevita for use in the EU in March 2017. However, due to patent litigation with Abbvie, the launch was delayed. Amgen signed a licensing agreement with Abbvie, which concludes continuing patent litigation and enabled Amgen to launch in the EU in October 2018. Under the agreement, Amjevita will launch in the US in January 2023, and Amgen will pay royalties to Abbvie on its sales.
About the Manufacturer
Amgen, based in Thousand Oaks, California, is a leading global biotechnology company. The company focuses on six therapeutic areas: cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Amgen has two reference products that are currently facing biosimilar competition (filgrastim and pegfilgrastim), but they also have five biosimilars. These include the approved product Mvasi (bevacizumab-awwb), two products that have been filed with the FDA for approval (trastuzumab, infliximab), and three products in earlier stages of the pipeline (rituximab, cetuximab, and eculizumab).
News, Commentary, and Intelligence
Competitor Products and Manufacturer Analysis
Amjevita was the third adalimumab biosimilar to be approved by the FDA. It, like its competitors, is not yet available on the US market.
ADALIMUMAB BIOSIMILARS APPROVED BY THE FDA: FDA FILING DATES AND ACTIONS
ADALIMUMAB BIOSIMILARS IN DEVELOPMENT
FDA Approves Biosimilars for Adalimumab and Rituxumab
Boehringer Ingelheim Gives up the Fight, Signs AbbVie Agreement on Adalimumab
(May 15, 2019) This agreement allows Boehringer Ingelheim to enter the marketplace July 1, 2023, getting a slight jump on some other licensees, but it effectively ends the protracted patent litigation that Boehringer hoped to win.
Update: Who Has Signed Abbvie Licensing Agreements for Adalimumab Biosimilars?
(January 28, 2019) At least 8 biosimilar manufacturers have signed licensing agreements with Abbvie, which allow immediate European launches for approved adalimumab biosimilars and sequentially timed US launches in 2023. This database displays the manufacturer, product name, and date of anticipated launch. Note: not all of these biosimilar adalimumab are approved in the US.
More Adalimumab News: Abbvie Signs a Licensing Deal With Coherus, Coherus Sues Amgen for Patent Infringement
(January 28, 2019) Coherus becomes the eighth biosimilar maker to sign a licensing agreement with Abbvie, and it also becomes the first biosimilar maker to sue another (Amgen) for patent infringement.
Pfizer Pulls One Biosimilar Adalimumab Application From the EMA
(December 17, 2018) Earlier this month, Pfizer notified the European Medicines Agency (EMA) that it was withdrawing one of its two applications for approval of its biosimilar adalimumab.
Boehringer Ingelheim Decides to Market Cyltezo® in the US Only
(November 28, 2018) Boehringer has now announced its intention to discontinue all efforts to market and develop any biosimilars outside of the US market.
Pfizer Signs Licensing Deal With Abbvie on Adalimumab Biosimilar Candidate
(November 27, 2018) According to the announcement, Pfizer will market this agent (PF-06410293), if approved by the Food and Drug Administration, in November 2023.
A Third Biosimilar Adalimumab Approval in the US
(November 1, 2018) The Food and Drug Administration (FDA) announced yesterday the approval of adalimumab-adaz from Sandoz. The new agent, dubbed Hyrimoz™, will not be launched in the US until 2023.
Word From the Adalimumab Front: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 2
(October 24, 2018) In part two and the conclusion of this interview, Molly Burich, MS, Director, Public Policy: Biosimilars and Pipeline, speaks to Boehringer Ingelheim’s progress in Cytelzo interchangeability studies, its plans for the product in Europe in the face of several adalimumab biosimilars launches in the EU, and also the complexity inherent in CMS’s plans to move biologic agents from part B to part D coverage.
Word From the Adalimumab Front: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 1
(October 23, 2018) In the first portion of a two-part interview with Molly Burich, MS, Director, Public Policy: Biosimilars and Pipeline, Boehringer Ingelheim, we cover the challenges of driving biosimilar uptake, as well as the unique situation that has focused this manufacturer’s attention on biosimilars and interchangeability.
Part B to Part D and Other Questions: How CMS’s Plans Could Affect Biosimilars
(August 10, 2018) Some of these tactics are a bit late to the party, as commercial insurers and health plans have been employing them for years. To the extent that an injectable treatment can be managed through the pharmacy benefit rather than the medical benefit, the drug can be easily subjected to prior authorization, step therapy, quantity limits, and other tools routinely used.
Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate
(August 3, 2018) A long-sought dream in the United States will be a welcome reality in Europe this October: a stampede for Abbvie’s marketshare with adalimumab biosimilars and the savings that go with it.
An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?
(June 22, 2018) In its recent investor conference, the company disclosed that it is ready to send M923, its adalimumab biosimilar, to the agency for approval.
With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market
(April 6, 2018) Samsung Bioepis and Biogen has reached a deal with Abbvie that would enable it to market its biosimilar adalimumab (should it be granted approval) in June 2023.
What Will Cost Savings on 2023 Adalimumab Biosimilars Really Be Worth?
(February 5, 2018) AbbVie executives are sticking to their pledge to restrict annual price increases on Humira® below 10%, but even payer price protections won’t mitigate the increasing expenditures before adalimumab biosimilars hit the market.
Sandoz Files 351(k) Application for Adalimumab Biosimilar
(January 16, 2019) Sandoz announced that it has thrown its hat in the ring for another Humira biosimilar.
Are We Now Thinking “Authorized Biosimilars”?
(October 3, 2017) Authorized generics have been around for a couple of decades. They can be a challenge to payers, health systems, and patients who are seeking the price-reduction benefits borne out of normal competition. The Amgen-Abbvie agreement for the former’s adalimumab biosimilar is right out of this playbook.
FDA Approves New Humira Biosimilar, Bypasses Advisory Board Route
(August 29, 2017) Boehringer Ingelheim Pharmaceuticals, Inc. announced August 29 that it had received approval from the Food and Drug Administration (FDA) for its first biosimilar.
Boehringer May Seek Interchangeable Designation for Adalimumab Biosimilar
(July 28, 2017) One biosimilar developer announced on July 27 that it is embarking on a study specifically to prove interchangeability of its biosimilar version of adalimumab.
A Possible Clinical Benefit for Amjevita
(March 31, 2017) According to researchers findings, Amjevita was associated with less injection-site pain compared with Humira, based on pain scores given by clinical trial patients with moderate to severe rheumatoid arthritis.
The FDA Approves First Biosimliar to Humira
(September 23, 2016) The FDA approved the first biosimliar version of adalimumab (reference product, Humira). The approval extends to six indications of the originator product.
Impressions on the Adalimumab Biosimilar Arthritis Advisory Committee Meeting
(July 12, 2016) FDA Advisory Committee members considered the data package provided by Amgen to be comprehensive, but the 26-0 vote was not without some interesting points and drama.