• Samsung Bioepis secures third FDA approval in the past seven months
• Samsung Bioepis becomes the first company to receive FDA approval for biosimilars referencing all three anti-TNF medicines.


INCHEON, Korea – July 24, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab)ⁱ , for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. Please see full indications and Boxed Warning for HADLIMA™, below.
 

HADLIMA™ is Samsung Bioepis’ third anti-TNF biosimilar approved for marketing in the United States (US). HADLIMA™ is also Samsung Bioepis’ fourth biosimilar approved in the U.S., following the approval of RENFLEXIS® (infliximab-abda) in April 2017, ONTRUZANT® (trastuzumab-dttb) in January 2019, and ETICOVO™ (etanercept-ykro) in April 2019.
 

"With the approval of HADLIMA, we are proud to have three anti-TNF biosimilars approved in the U.S. We believe the US healthcare system can benefit from biosimilars which could play a critical role in broadening access to treatment options for patients with autoimmune conditions across the country," said Hee Kyung Kim, Senior Vice President and Head of Regulatory Affairs, Samsung Bioepis. “We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems can benefit from biosimilars.”
 

In addition to the U.S., Samsung Bioepis’ adalimumab biosimilar has been approved for marketing in over 30 countries, including 28 European Union (EU) member states, Canada, Australia and Korea.
 

HADLIMA™ will be commercialized in the U.S. by Merck, also known as MSD outside of the US and Canada. HADLIMA™ is expected to launch in the U.S. after June 30, 2023, in accordance with a licensing agreement signed with AbbVie Inc.
 

The FDA approval was based on data derived from a randomized, double-blind 52-week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either HADLIMA™ or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the HADLIMA™ group versus 72.2% in the ADL group. The safety profile of HADLIMA™ was comparable to ADL up to Week 24. At Week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transition to HADLIMA™, and 254 patients receiving HADLIMA™ continued to receive HADLIMA™. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.

 

About HADLIMA™ (adalimumab-bwwd)
HADLIMA™ is a tumor necrosis factor (TNF) blocker approved in the U.S. for the following indications:
 

Rheumatoid Arthritis (RA) - HADLIMA™ is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HADLIMA™ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
 

Juvenile Idiopathic Arthritis (JIA) - HADLIMA™ is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. HADLIMA™ can be used alone or in combination with methotrexate.
 

Psoriatic Arthritis (PsA) - HADLIMA™ is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HADLIMA™ can be used alone or in combination with non-biologic DMARDs.
 

Ankylosing Spondylitis (AS) - HADLIMA™ is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
 

Adult Crohn’s Disease (CD) - HADLIMA™ is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. HADLIMA™ is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products.
 

Ulcerative Colitis (UC) - HADLIMA™ is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7)].
 

Plaque Psoriasis (Ps) - HADLIMA™ is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA™ should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning and Warnings and Precautions (5)].

 

Select Important Safety Information
 

WARNING: Serious Infections and Malignancies
 

SERIOUS INFECTIONS
Patients treated with adalimumab products including HADLIMA™ are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections and infections due to other opportunistic pathogens.
Discontinue HADLIMA™ if a patient develops a serious infection or sepsis. Test patients for latent tuberculosis before HADLIMA™ use and during therapy. Initiate treatment for latent tuberculosis prior to HADLIMA™ use.
 

MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

These are not all of the risks associated with HADLIMA™. The HADLIMA™ Prescribing Information carries warnings regarding serious infections, malignancies, hypersensitivity reactions including anaphylaxis and angioneurotic edema, Hepatitis B virus reactivation, neurologic and hematological reactions, use with Anakinra, heart failure, autoimmunity, immunizations, and use with Abatacept. Please see Prescribing Information for HADLIMA™ (adalimumab-bwwd) HERE.
 

ⁱ HUMIRA® is a registered trademark of AbbVie Inc.

MEDIA CONTACT:
Na Yun KIM
+82-31-8061-1604
nayun86.kim@samsung.com