Product Profile:

Adalimumab-bwwd (Hadlima)

Drug Category: anti-TNF inhibitor/autoimmune

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

Manufactured by Samsung Bioepis; will be marketed by Merck

Biosimilar Drug Profile: Hadlima is an FDA-approved biosimilar version of adalimumab (reference product, Humira®, AbbVie).

Originally known as SB5, Samsung Bioepis submitted a biologic license application for approval via the 351(k) biosimilar pathway on September 27, 2018. The Food and Drug Administration (FDA) approved the biosimilar on July 2, 2019 (without convening its Advisory Committee). The European Medicines Agency approved the biosimilar drug (under the name Imraldi) on June 26, 2016.

Though approved, it is not yet marketed in the US  Like several other manufacturers of approved biosimilar versions of adalimumab, Samsung has signed a licensing agreement with AbbVie; under the agreement, Samsung would be able to launch the drug in late June 2023.

About the Manufacturer

Samsung Bioepis Co., Ltd. develops and produces biopharmaceutical and biosimilar products. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen that operates as a subsidiary of Samsung Biologics Co., Ltd.  In Early 2013 Samsung Bioepsis and Merck entered into a business agreement to develop and commercialize biosimilars. Samsung Bioepis Co., Ltd. also entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited in August 2017. The company was incorporated in 2012 and is based in Incheon, South Korea.

Beyond Hadlima, Samsung Bioepis has several approved biosimilars in the US: Renflexis (infliximab-abda), Eticovo (etanercept-yrko), and Ontruzant (trastuzumab-dttb). Only Renflexis is currently available for prescription in the US. Samsung Bioepis’ pipeline includes biosimilars in various stages of development for bevacizumab, ranibizumab, and eculizumab.

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

Hadlima was the fourth adalimumab biosimilar to be approved by the FDA. It, like its competitors, is not yet available on the US market because of licensing agreements signed with the manufacturer of the reference product, AbbVie.



Brand Name & Designation

Filing Date

Approval Date/Marketing Status


Amjetiva (adalimumab-atto)

November 25, 2015

Approved September 23, 2016, all indications; not yet marketed; Signed licensing agreement with AbbVie to launch January 2023

Boehringer Ingelheim

Cyltezo (adalimumab-adbm) 

January 18, 2017

Approved August 29, 2017; Signed licensing agreement with AbbVie to launch July 2023


Hyrimoz (adalimumab-adaz)

January 16, 2018

Approved October 31, 2018; Signed licensing agreement with AbbVie to launch Sept 2023

Samsung Bioepis

Hadlima (adalimumab-bwwd)

September 27, 2018

Approved July 22, 2019; Signed licensing agreement with AbbVie to launch June 2023


Abrilada (adalimumab-afzb)

Q4 2018

Approved November 18, 2019; Signed licensing agreement with AbbVie to launch November 2023

Mylan/Fujifilm Kyowa Kirin Biologics

Hulio (adalimumab-fkjp

Q4 2019

Approved July 6, 2020; Signed licensing agreement with AbbVie to launch August 2023

Company Name Product Name Stage of Development
Coherus Biosciences CHS-1420 Submitted 351(k) application December 2020; FDA decision expected Q4 2019
Fresenius Kabi MSB11022 Completed phase 3 study; FDA filing may occur in 2021
Celltrion CT-P17 Phase 3 trials completed; FDA filing may occur in 2021

Adalimumab Biosimilar Approval for Mylan and Fujifilm Kyowa Kirin

(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. Officially dubbed Hulio® (adalimumab-fkjp), this 28th approved biosimilar will be first available for prescription in August 2023,

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.

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The Benefits of Biosimilars

The Promise of Biosimilars

Clinical Trials of Hadlima

Phase 3 Trials

Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate‐to‐Severe Rheumatoid Arthritis

This study was conducted in 6 European countries and South Korea. These investigators compared SB5 (Hadlima) with EU-sourced Humira in 544 patients with rheumatoid arthritis (RA).

The population of this randomized, double-blind trial comprised patients whose symptoms of moderate to severe RA did not alleviate despite use of methotrexate. Patients received either the biosimilar or reference drug 40 mg subcutaneously every other week. The primary outcome measure the response rate based on the American College of Rheumatology 20% improvement criteria (ACR20) at week 24 (per‐protocol analysis). Secondary outcome measures included ACR50 and ACR70, safety, and immunogenicity assessments.

A total of 476 patients completed the study and were analyzed as the per protocol population (239 given SB5, 237 given Humira). The main results from the per protocol analysis are described in the Table below:


SB5 (n = 239)

Humira (n = 237)

EULAR Moderate Response (wk 24)



EULAR Good Response (wk 12)



EULAR Good Response (wk 24)



ACR20 (wk 24)



ACR50 (wk 24)



ACR70 (wk 24)



Treatment-Emergent Adverse Events (TEAEs)  (wk 24)



Serious TEAEs



Presence of Antidrug Antibodies



The investigators reported that the results seen in the full analysis set were comparable. With the similarity in the results of SB5 and EU-licensed Humira, the researchers concluded that these agents provided equivalent outcomes at 24 weeks in patients with RA.

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis

Fifty‐Two–Week Phase III Randomized Study Results

Based on the 24-week study described above, investigators conducted a switching study between SB5 and EU-licensed Humira in these patients with RA. The study groups were followed through 52 weeks of treatment.

This trial was also conducted as a randomized, double-blind study. After the initial 24 weeks of therapy were completed, participants were rerandomized to receive either adalimumab (i.e., continuing on their reference drug therapy) or switch to biosimilar treatment (both treatments given as 40 mg subcutaneous injections every other week).

The ACR efficacy results of the switching study are presented below:


Switched to SB5 (n = 125)

Continue on Humira (n = 129)

ACR20 (wk 52)



ACR50 (wk 52)



ACR70 (wk 52)



No statistically significant differences were seen in these results or for DAS28 or EULAR response scores. The same was true of radiographic evidence of joint damage.

The researchers did note a trend towards lower efficacy scores in patients with antidrug antibodies (in all treatment groups). However, they found that safety measures were equivalent among switched and nonswitched groups.

They concluded that switching from reference product to the biosimilar was not associated with negative safety and clinical efficacy outcome.

Phase 2 Studies

An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

Phase 1 Studies

Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

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