Merck known as MSD outside the United States and Canada, has announced the US launch of Renflexis (infliximab-abda), a biosimilar of the originator biologic medicine Remicade (infliximab).
Renflexis was approved by the US Food and Drug Administration (FDA) on April 21 for all eligible indications. Renflexis is the first medicine available in the US under a global biosimilars development and commercialization agreement between Merck and Samsung Bioepis Co., Ltd.
“Merck looks forward to launching Renflexis in the United States to help meet the needs of patients, physicians and payers,” said Dora Bibila, general manager, Merck Biosimilars. “As a global health care leader, Merck believes that biosimilars have the potential to help increase access to these important medicines while also providing savings for the health care system.”
Renflexis will be introduced in the US at a list price (wholesaler acquisition cost) of $753.39, representing a 35 percent discount to the current list price of Remicade, its reference product. Wholesaler acquisition costs do not include discounts that may be paid on the products.
Serious and sometimes fatal side effects have been reported with infliximab products. Infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens (e.g., TB, histoplasmosis) have been reported. Lymphoma, including cases of fatal hepatosplenic T-cell lymphoma (HSTCL), and other malignancies have been reported, including in children and young adult patients. Due to the risk of HSTCL, mostly reported in Crohn’s disease and ulcerative colitis, assess the risk/benefit, especially if the patient is male and is receiving azathioprine or 6-mercaptopurine treatment. Renflexis is contraindicated in patients with severe hypersensitivity reactions to infliximab products and certain patients with congestive heart failure. Other serious side effects reported include melanoma and Merkel cell carcinoma, hepatitis B reactivation, hepatotoxicity, hematological events, hypersensitivity, neurological events, and lupus-like syndrome.
Launch resources will include comprehensive education and support services for health care professionals, patients and their caregivers, including biosimilars education, disease education, and reimbursement and access support.
The FDA approval of Renflexis (infliximab-abda) was based on Samsung Bioepis’ comprehensive data package, including analytical, nonclinical and clinical pharmacokinetic, safety and effectiveness data demonstrating that Renflexis is highly similar to its reference product Remicade, in terms of the safety, purity and potency of the product.
Renflexis is a tumour necrosis factor (TNF) blocker approved in the US for the following indications.
Crohn’s disease – Renflexis 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. Renflexis is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease.
Paediatric Crohn’s disease – Renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
Ulcerative colitis – Renflexis is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
Rheumatoid arthritis – Renflexis, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.
Ankylosing spondylitis – Renflexis is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Psoriatic arthritis – Renflexis (infliximab-abda) is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.
Plaque psoriasis – Renflexis is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. Renflexis should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Merck introduces, biosimilar, remicade, us market
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