FDA Approves ETICOVO™ (etanercept-ykro), Samsung Bioepis’ Second Anti-TNF Medicine in the United States

INCHEON, Korea--(BUSINESS WIRE)-- Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved ETICOVO™ (etanercept-ykro), a biosimilar referencing ENBREL^® (etanercept), across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. ETICOVO™ is Samsung Bioepis’ second anti-TNF biosimilar approved for marketing in the United States (US).

“The approval of ETICOVO adds to our growing portfolio of anti-TNF medicines in the US, where we believe biosimilars can bring meaningful value to the country’s healthcare system,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines.”

In addition to the US, Samsung Bioepis’ etanercept biosimilar has been approved for marketing in 38 countries, namely 28 European Union (EU) member states, the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein, as well as Switzerland, Canada, Brazil, Australia, New Zealand, Israel, and Korea.

In a 52-week Phase III clinical study, which randomized 596 patients with rheumatoid arthritis across 70 sites in 10 countries, ETICOVO™ demonstrated comparable safety and efficacy to the etanercept reference product (ENBREL^®), as evidenced in ACR20 response rate of 80.8% in the ETICOVO™ arm versus 81.5% in the ENBREL^® arm.ⁱⁱ This confirmed the 24-week study results of 78.1% in the ETICOVO™ arm versus 80.3% in the ENBREL^® arm.ⁱⁱⁱ

About ETICOVO™ (etanercept-ykro)

ETICOVO™ is a tumor necrosis factor (TNF) blocker approved in the US for the following indications:

Rheumatoid Arthritis - ETICOVO™ is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). ETICOVO™ can be initiated in combination with methotrexate (MTX) or used alone.

Polyarticular Juvenile Idiopathic Arthritis - ETICOVO™ is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.

Psoriatic Arthritis - ETICOVO™ is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). ETICOVO™ can be used with or without methotrexate.

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

Plaque Psoriasis - ETICOVO™ is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Warning: Serious Infections and Malignancies

SERIOUS INFECTIONS

Patients treated with etanercept products are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

ETICOVO™ should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before ETICOVO™ use and during therapy. Treatment for latent infection should be initiated prior to ETICOVO™ use.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with ETICOVO™ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ETICOVO™, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including etanercept products.

These are not all of the risks associated with ETICOVO™. The ETICOVO™ Prescribing Information carries warnings regarding serious infections, neurologic reactions, malignancies, patients with heart failure, hematologic reactions, Hepatitis B reactivation, allergic reactions, immunizations, autoimmunity, immunosuppression, use in Wegener’s Granulomatosis patients, use with Anakinra or Abatacept and use in patients with moderate to severe alcoholic hepatitis. Please see Prescribing Information for ETICOVO™ (etanercept-ykro) HERE.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology and ophthalmology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

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ⁱ ENBREL^® is a registered trademark of Amgen/Pfizer

ⁱⁱ Emery P, Vencovsky J, Sylwestrzak A et al. 52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis. Rheumatology (Oxford) 2017; 56:2093–101.

ⁱⁱⁱ Emery P, Vencovsky J, Sylwestrzak A et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2017;76:51–57.

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