Product Profile:

Adalimumab-aqvh (Yusimry)

Drug Category: anti-TNF inhibitor/autoimmune

Target Indications: Treatment of ankylosing spondylitis, Crohn’s disease, plaque psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis

Will be manufactured and marketed by Coherus BioSciences

Summary: Yusimry is the seventh FDA-approved version of adalibumab (reference product Humira®, manufactured by AbbVie).

Originally known as CHS-1420, Coherus BioSciences submitted a biologic license application to the Food and Drug Administration (FDA) for approval via the 351(k) biosimilar pathway in February 2021. The biosimilar was approved on December 20, 2021. The company plans to launch Yusimry in the US on or after July 1, 2023, per the terms of an agreement with AbbVie. Under the terms of the agreement, Coherus will pay royalties to AbbVie on sales of Yusimry.

About the Manufacturer

Coherus BioSciences, located in Redwood City, California, is a commercial stage biopharmaceutical company that was founded in 2010 to develop and manufacture biosimilars. However, the company has expanded its portfolio to nonbiosimilar agents as well. A collaboration with Junshi Biosciences was announced in February 2021 to build its immune-oncology franchise. Currently, Coherus markets a pegfilgrastim biosimilar (Udenyca) and currently has biosimilars for ranibizumab and bevacizumab in development.

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

Like its competitors, Yusimry is not yet available on the US market because of licensing agreements signed with AbbVie, the manufacturer of the reference product Humira. In addition to the 7 adalimumab biosimilars approved by the FDA (including at least one interchangeable product), an additional 3 are expected to be ready to launch by the end of 2023. It should be noted that these biosimilars vary somewhat by formulation (citrate-free/non-citrate free, high-concentration/low-concentration, needle size).



Brand Name & Designation

Filing Date

Approval Date/Marketing Status


Amjetiva (adalimumab-atto)

November 25, 2015

Approved September 23, 2016, all indications; not yet marketed; To launch January 2023

Boehringer Ingelheim

Cyltezo (adalimumab-adbm) 

January 18, 2017

Approved August 29, 2017; FDA designated as Interchangeable; To launch July 2023


Hyrimoz (adalimumab-adaz)

January 16, 2018

Approved October 31, 2018; To launch July 2023

Samsung Bioepis

Hadlima (adalimumab-bwwd)

September 27, 2018

Approved July 22, 2019; To launch June 2023


Abrilada (adalimumab-afzb)

Q4 2018

Approved November 18, 2019; Seeking Interchangeable status; To launch July 2023

Viatris/Fujifilm Kyowa Kirin Biologics

Hulio (adalimumab-fkjp

Q4 2019

Approved July 6, 2020; To launch July 2023

Coherus Biosciences

Yusimry (adalimumab-aqvh)

February 2021

Approved December 20, 2021; To launch July 2023


Company Name

Product Name

Stage of Development



Approved by the European Commission on November 15, 2021. In the US the BLA is in deferred status, pending FDA inspections. Seeking Interchangeability designation. The company is hoping for a July 2023 launch



Considered a high concentration, low-volume biosimilar. Phase III studies are completed. Filed with the FDA in November 2020. Status not known. Approved by the EU in February 2021

Fresenius Kabi


Received EU approval in 2019. FDA submission status not disclosed. Company is hoping for a September 2023 launch

Stocking and Delivering: The Block and Tackle Issues for Adalimumab Biosimilars

(March 14, 2022) The infusion of competition into the adalimumab category will pretty much guarantee one concern will be true—the need for health systems and specialty pharmacies in particular—to stock virtually all brands, reference and biosimilars. The reason is simple: Different insurers will cover a range of products.

Adalimumab Interchangeability Competition Coming into Focus

(March 1, 2022) Pfizer announced on February 25 that the Food and Drug Administration had accepted a supplemental 351(k) application for its adalimumab biosimilar Abrilada™, in an attempt to gain the interchangeability designation. This is just one development in clarifying the upcoming adalimumab interchangeability competition.

Samsung Bioepis Submits Supplemental Application for Citrate-Free, High-Concentration Adalimumab Biosimilar

(January 10, 2022) In an effort to more closely match the options available with AbbVie’s reference product, partners Samsung Bioepis and Organon sent the US Food and Drug Administration a supplemental 351(k) application for a citrate-free, 100-mg/mL form of Hadlima™.

Coherus Secures FDA Approval on Yusimry™, Its Adalimumab Biosimilar

(December 23, 2021) On December 20, Coherus Biosciences announced that the Food and Drug Administration approved Yusimry (adalimumab-aqvh). This is Coherus’ second biosimilar approval. In 2017, Coherus completed a randomized, controlled phase 3 study involving 545 patients with moderate-to-severe plaque psoriasis, comparing the biosimilar to the reference product.

Amgen, Pfizer Now Seeking Adalimumab Interchangeability, but…

(November 16, 2021) At its third-quarter conference, Amgen announced that it is enrolling patients in a multiple-switching trial in an effort to obtain the interchangeability designation for Amjevita®. Amgen’s phase 3 study began in early October and is scheduled to be completed in April 2023.

FDA Designates Boehringer Ingelheim’s Cyltezo® as First Interchangeable Adalimumab Biosimilar

(October 18, 2021) On October 15, Boehringer Ingelheim formally secured its long-sought adalimumab interchangeability designation from the Food and Drug Administration (FDA). This label was earned based primarily on the results of Boehringer’s VOLTAIRE-X switching studies. The VOLTAIRE-X study demonstrated that patient efficacy or safety outcomes were not affected by multiple switches between Cyltezo and Humira®.

Adalimumab Biosimilar Approval for Mylan and Fujifilm Kyowa Kirin

April 21 2021) As we inch closer to the January 2023 date for the launch of the first US adalimumab biosimilar, industry watchers are more closely scrutinizing which company, if any, will have a competitive advantage in this lucrative marketplace.

Further Dissecting the Launch of Adalimumab Biosimilars in the US

(July 6, 2020) On July 6, the Food and Drug Administration approved partners Mylan/Fujifilm Kyowa Kirin Biologics’ biosimilar version of adalimumab for use in patients with autoimmune diseases.

Pfizer Reaches Milestone: FDA Approves 25th Biosimilar in US

(November 20, 2019) Pfizer announced November 18th that the biosimilar licensing application (BLA) for its adalimumab biosimilar was approved by the Food and Drug Administration (FDA).

Momenta Drops Out of Biosimilar Adalimumab Competition

(August 5, 2019) “Today, Momenta announced the Company will cease active development of M923 at this time, due to changes in the market opportunity associated with Humira patent litigation settlements,” according to a company press release.

The Biosimilar Mabs Have It: FDA Approves Samsung Bioepis' Adalimumab

(July 24, 2019) In a busy beginning of the week, the US Food and Drug Administration approved new biosimilars for Humira and RituxanSamsung Bioepis gained approval for Hadlima™ (adalimumab-bwwd), and Pfizer scored with Ruxience™ (rituximab-pvvr).

Samsung Bioepis Signals a Settlement With Genentech on Herceptin Biosimilar

(July 12,  2019) Samsung Bioepis and Genentech filed a motion in District Court to drop all pending patent litigation regarding Ontruzant, an approved Herceptin biosimilar.

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.

Impressions on the Adalimumab Biosimilar Arthritis Advisory Committee Meeting

(July 12, 2017) 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.

Adalimumab BIosimilars Introduced in Europe

The Promise of Biosimilars

Clinical Trials of Yusimry

Phase 3 Trials

One phase 3 trial was conducted in the commercial development of Yusimry, in the indication of plaque psoriasis. Four phase 1 trials to evaluate pharmacokinetics (in healthy volunteers) were also conducted.

Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis (PsO).

A randomized, parallel-group, active-controlled study, conducted in three phases (the final phase was an open-label extension study), compared the efficacy and safety of the biosimilar CHS-1420 with that of US-sourced Humira in 545 patients (mean age, 43.9 yr; 72.3% male; 92.7% Caucasian) with chronic plaque psoriasis. None of the patients had received anti-TNF therapy in the past.

In the first phase, patients received either CHS-1420 or Humira 80 mg subcutaneously as the first dose and then 40 mg subcutaneously every other week for 16 weeks. In the second phase, those receiving CHS-1420 continued to receive the biosimilar, whereas half of those in the reference product group were switched to the biosimilar. After week 24, all patients achieving at a least a 50% improvement in the Psoriasis Area and Severity Index (PASI 50) continued on in a 23-week open-label study of CHS-1420. The study subjects had a mean baseline PASI of 24.5.

The primary endpoint was the percent of patients achieving a 75% improvement in PASI (PASI 75) at week 12 relative to baseline. Of note, the FDA recommended the change in PASI score be calculated at week 16. Secondary endpoints included PASI 75 at several other times points, percentage changes in PASI from baseline, and PASI 50 and PASI 90 improvement at several time points.

The researchers found that by weeks 12 and week 16 the mean PASI improvement scores were equivalent, with patients receiving CHS-1420 achieving a 77.0% improvement compared with those receiving Humira attaining a 84.9% improvement in PASI scores.

In terms of secondary PASI endpoints at weeks 12 and 16, the percentage of patients achieving PASI 50, 75, and 90 were not significantly different.



(N = 274)


(N = 271)

Week 12


242 (88.3%)

247 (91.1%)


211 (77.0%)

203 (74.9%)


145 (52.9%)

142 (52.4%)

Week 16


247 (90.1%)

241 (88.9%)


221 (80.7%)

209 (77.1%)


141 (58.8%)

165 (60.9%)


Throughout the time points response rates were similar. The percentages of patients achieving PASI 90 at week 24 were 70.3% for the 259 patients taking CHS-1420 and 66.7% for the 129 individuals continuing on Humira therapy. During the open-label portion, 75.2% of those who had taken CHS-1420 for all 48 weeks, compared with 59.6% who switched to CHS-1420 for the final 16 weeks of open-label treatment.

Treatment-emergent serious adverse events (TESAE) were similar for each group at week 12 as noted in table below:

Serious Adverse Events



Reference product US adalibumab



4 (1.5%)

6 (2.2%)

Acute myocardial infarction

1 (0.4%)




1 (0.4%)



1 (0.4%)



1 (0.4%)



1 (0.4%)



1 (0.4%)

Diabetic ketoacidosis


1 (0.4%)

Psoriatic arthropathy

1 (0.4%)


Rotator cuff syndrome

1 (0.4%)


Chronic and obstructive pulmonary disease


1 (0.4%)

Psoriasis (worsening)

1 (0.4%)



Antidrug antibodies were noted in 90% of the biosimilar group and 94% of the reference product group. Neutralizing antibody formation was similar, 33% biosimilar group vs. 34% reference product group.

The investigators concluded that the data accumulated through the trial confirmed the biosimilar and reference produced similar outcomes and there were no significant differences in the safety profiles of the two products.

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