INFLECTRA® (Infliximab-Dyyb) Product Monograph Supporting Biosimilarity
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FDA-APPROVED The first FDA-approved biosimilar for Remicade® (infliximab)1,2 INFLECTRA® (infliximab-dyyb) Product Monograph Supporting Biosimilarity IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with iniximab products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue INFLECTRA® (iniximab-dyyb) if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before INFLECTRA® use and during therapy.1,2 Treatment for latent infection should be initiated prior to INFLECTRA® use. • Invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients may present with disseminated, rather than localized, disease. 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. INFLECTRA® is a trademark of Hospira UK, a Pfizer company. ® Remicade is a registered trademark of Janssen Biotech. Important Safety Information continued on Page 5. Please see additional Important Safety Information throughout, Indications on the last page, and full Prescribing Information, including BOXED WARNING and Medication Guide, available at InflectraHCP.com. FDA-APPROVED Table of Contents Section 1 Executive summary . .5 Section 2 About INFLECTRA . .6 2.1 Appropriate patients . 6 2.2 Dosing and administration . 7 Section 3 Support for biosimilarity . .8 3.1 Basics of biologics . 8 3.2 Structural and functional similarity . 10 Section 4 Clinical studies supporting biosimilarity . .12 4.1 INFLECTRA in healthy volunteers . 12 4.2 INFLECTRA in ankylosing spondylitis (AS) . 13-17 4.3 INFLECTRA in rheumatoid arthritis (RA) . 18-22 4.4 INFLECTRA in Crohn's disease (CD) . 23-25 4.5 Extrapolation . 26-27 Section 5 Reimbursement and access . .28 Section 6 Important Safety Information and Indications . .29-Back cover 2 Please see additional Important Safety Information throughout, Indications on the last page, and 3 full Prescribing Information, including BOXED WARNING and Medication Guide, available at InflectraHCP.com. FDA-APPROVED Section 1: Executive summary INFLECTRA is the first FDA-approved biosimilar for Remicade® (infliximab)1,2 • A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product3 • Shown to be highly similar to Remicade, with no clinically meaningful differences in terms of efficacy, immunogenicity, safety profile, or purity4 – Similar pharmacokinetic (PK) profile to EU Remicade and US Remicade in healthy volunteers4 – Similar pharmacokinetic (PK) profile to Remicade in patients with ankylosing spondylitis (AS)4 – Similar efficacy to Remicade in rheumatoid arthritis (RA) in a 54-week study4,5 – In controlled RA and AS studies, no significant differences vs Remicade in adverse events of special interest (AESI)4 – In 2 clinical studies, rates of antidrug antibody (ADA) positivity were similar between INFLECTRA and Remicade, including patients who transitioned from Remicade to INFLECTRA and remained on INFLECTRA in 1-year extensions4 – Efficacy and safety of INFLECTRA were observed to be similar to Remicade in a clinical study in patients with active Crohn’s disease (CD)5 • Efficacy and safety profile were demonstrated in RA and AS and extrapolated to all other eligible indications4 – The FDA determined that extrapolation was appropriate for INFLECTRA with regard to Remicade indications that were not studied4 INFLECTRA reimbursement and access support from Pfizer enCompass™ • Pfizer enCompass™ is a comprehensive resource for information and resources related to reimbursement and patient access for INFLECTRA IMPORTANT SAFETY INFORMATION (Continued) SERIOUS INFECTIONS (Continued) The risks and benets of treatment with INFLECTRA® 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 INFLECTRA®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection. Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other 4 Please see additional Important Safety Information throughout, Indications on the last page, and serious infections observed in patients treated with infliximab products included pneumonia, cellulitis, abscess, 5 full Prescribing Information, including BOXED WARNING and Medication Guide, available at InflectraHCP.com. and skin ulceration. FDA-APPROVED Section 2. About INFLECTRA® (infliximab-dyyb) pg 20 2.1: Appropriate patients 2.2: BIOSIMILARDosing and GUIDANCE administration SCIENTIFIC JUSTIFICATION Approved for all eligible indications of Remicade® (infliximab)1 Dosed identically to Remicade1 • Moderate to severely active rheumatoid arthritis (RA)* • Moderate to severely active ulcerative colitis (UC)† Dosing varies by indication through IV infusion over a period of not less 1 • Active ankylosing spondylitis (AS) • Active psoriatic arthritis (PsA) thanDosing 2 varieshours by indication through IV infusion over a period of not less than 2 hours • Moderate to severely active Crohn’s disease (CD)† • Chronic severe plaque psoriasis (PsO)‡§ RA AS CD PEDIATRIC CD UC/PsA/PsO • Moderate to severely active pediatric CD† In conjunction with 5 mg/kg at 0, 2, and 5 mg/kg at 0, 2, and 5 mg/kg at 0, 2, and 5 mg/kg at 0, 2, and *In combination with methotrexate. For full Indications, see back cover. methotrexate, 3 mg/kg 6 weeks, and then 6 weeks, and then 6 weeks, and then 6 weeks, and then †In patients who have had an inadequate response to conventional therapy. at 0, 2, and 6 weeks, every 6 weeks every 8 weeks every 8 weeks every 8 weeks ‡Patients who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. and then every 8 weeks §INFLECTRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Some adult patients INFLECTRA can be Some patients may who initially respond to administered with or benefit from increasing treatment may benefit without methotrexate the dose up to from increasing the for the treatment 3 10 mg/kg or treating as dose up to 10 mg/kg if of PsA Can be considered for all patients appropriate for Remicade for the above indications often as every 4 weeks they later lose their response Patients new Patients currently stable to infliximab therapy on Remicade Product packaging and supply 1 INFLECTRA does not have a designation of interchangeability with Remicade. For injection: 100 mg of lyophilized infliximab-dyyb in a 20-mL vial for intravenous infusion. According to the Food and Drug Administration (FDA): " Biosimilars…can be used in patients who have previously been treated with the reference product (treatment experienced), as well as in patients who have not previously received the reference product (treatment naïve).”4 IMPORTANT SAFETY INFORMATION (Continued) MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including iniximab products. Approximately half of these cases were lymphomas, including Hodgkin’s IMPORTANT SAFETY INFORMATION (Continued) and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies MALIGNANCIES (Continued) that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients patients were receiving concomitant immunosuppressants. treated with TNF blockers, including iniximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all patients had received treatment with azathioprine or 6 Please see additional Important Safety Information throughout, Indications on the last page, and 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Carefully assess the risks and benets of 7 full Prescribing Information, including BOXED WARNING and Medication Guide, available at InflectraHCP.com. treatment with INFLECTRA®, especially in these patient types. FDA-APPROVED Section 3: Support for biosimilarity 3.1: Basics of biologics About biologics3 Example of variability between different INFLECTRA is shown to be highly similar to Remicade® (infliximab), with no clinically batches of a biological medicine6: