Infimab (infliximab biosimilar) / Sun Pharma, Reliance Life Sci - LARVOL DELTA

COMPARATIVE ANALYSIS OF THE LONG TERM EFFICACY AND SAFETY OF BIOSIMILAR INFLIXIMAB ADMINISTERED BY CONVENTIONAL DOSAGE REGIMEN VERSUS MODIFIED DOSAGE REGIMEN IN REAL-LIFE CLINICAL SETTINGS: A MULTI-CENTRE STUDY (EULAR 2024) - "Objectives: This multicentre study assessed the long-term efficacy and safety of Infliximab biosimilar (Infimab) administered via a conventional dosage regime [infliximab at 5 mg/kg at week 0, 2, and 6 (induction period) followed by 5 mg/kg every 6–8 weeks (maintenance period)] compared to a modified dosage regime [infliximab at 5 mg/kg at week 0 and 2 (induction period) followed by 3 mg/kg at week 6 and then 8-weekly (maintenance period)] in patients with AS during routine clinical practice... The modified dosage regime was found to be non-inferior to the conventional dosage regime in patients with AS. The approach of dose reduction would have valuable implications in substantially increasing affordability and medical cost savings. A dose reduction would also enable lowering the incidence of serious adverse events."

Clinical • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

Biosimilars as Effective as Originator Biologics in IBD (Medscape) - "Commenting on the findings for Medscape, Stephen B. Hanauer, MD...said, 'This review summarizes 43 individual studies that basically all say the same thing in one aspect or another: that they meet the criteria for biosimilar approval, which means they act just like the originator product.' Hanauer did not participate in the study. 'Approved biosimilar infliximab is infliximab, and approved biosimilar adalimumab is adalimumab.'...The data that provided the basis for the 2019 joint position statement were 'more limited,' said Marshall. 'Since then, there's been much more observational data that has provided reassurance. It may be that if that group repeated their review with all the data that are now available, they might make a different conclusion.'"

Media quote

IL-17 Inhibitors for the Treatment of Plaque Psoriasis - Episode 8-Future of Plaque Psoriasis Management (DermatologyTimes) - "Drs Mark G. Lebwohl and Alice B. Gottlieb discuss future expectations in the treatment of plaque psoriasis. Mark G. Lebwohl, MD: Based on the developments of the past several years and how the treatment armamentarium has expanded, what would you like to see emphasized in research development over the next several years? What do you think is realistically achievable...Alice B. Gottlieb, MD, PhD: I'd like to see better efficacy in psoriatic arthritis. That may involve treating it even earlier than we treat it on average. That's an area of opportunity. I'd like to see pills that do the same thing with the same safety profile."

Video • Psoriasis • Psoriatic Arthritis

Current Knowledge of Biologics in Treatment of Noninfectious Uveitis. (PubMed, J Ocul Pharmacol Ther) - "Other drugs include anti-CD20 inhibitors (rituximab), interleukin-6R-inhibitor (tocilizumab), Interleukin-1R-inhibitor (anakinra), Iinterleukin-2-inhibitor (daclizumab), and the list is further increasing. New advances in biologics are the biosimilar molecules, which are biological products that are highly similar to the reference product, and they include Infimab (biosimilar of infliximab), Exemptia or Adfrar (biosimilar of adalimumab), and Intacept or Etacept (biosimilar of etanercept)...Thus, biologics are the future of uveitis treatment with promising results. This article aims to summarize the current knowledge on biologics and their clinical utility in the management of NIU."

Journal • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Ocular Inflammation • Oncology • Ophthalmology • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis • IL1R1 • IL2 • IL6R

The Regueiro Report: Optimizing Anti-TNF Treatment for IBD (Gastroendonews) - "The first topic I chose to look at is the use of proactive therapeutic drug monitoring (TDM). Based on limited data, the practice is thought to improve outcomes, but the trial I've highlighted-which included patients with IBD and other illnesses treated with infliximab-showed that decisions based on proactive TDM did not increase the likelihood of clinical remission compared with decisions based on clinical features alone. The findings should make us question the usefulness of proactive TDM in all patients."

Blog

Therapeutic Methylprednisolone and Infimab Decrease the Severity of Organ Dysfunction in Pancreatic Duct Ligation Model of Severe Acute Pancreatitis in Wistar Rats (IHPBA 2022) - No abstract available

Preclinical • Gastrointestinal Disorder • Hepatology • Pancreatitis

The infectious profiles of biotherapeutic agents in an Algerian population (WCO-IOF-ESCEO 2016) - P=NA, N=107; “The products used were adalimumab (33.6 %) etanercept (29 %) rituximab (13 %) tocilizumab (13 %) and infliximab (11.2 %)…Infections events are more common in anti-TNFα treated patients than those on rituximab or tocilizumab.”

Clinical data • Biosimilar • Immunology

Epirus Biopharmaceuticals reports third quarter 2015 financial results & provides business update (Epirus Press Release) - "EPIRUS Biopharmaceuticals...today reported financial results for the third quarter of 2015, and provided a business update...Completed regulatory submissions for marketing authorization of BOW015 (Infliximab) in multiple countries in Southeast Asia, including Malaysia, Thailand and Indonesia...global filing anticipated in 2017 for marketing approval in Europe, US and Canada."; Anticipated global filing for: BOW050 in 2018, BOW070 in 2019, BOW080 in 2020, BOW090 in 2021 and BOW100 in 2022.

Anticipated BLA • Anticipated Canadian regulatory • Anticipated EU regulatory • Non-US regulatory • Biosimilar

Biosimilars for RA succeed in phase III (MedPageToday) - P3, N=294; Sponsor: Hanwha Chemical; NCT01270997 & P3, N=189; “In one trial…81.36% of patients receiving etanercept and 83.48% of those given the biosimilar HD203 had a 20% improvement according to the criteria of the American College of Rheumatology (ACR20) by 6 months (P=0.6706)… in a second trial…ACR20 responses at 4 months were seen in 86.4% and 89.9% of patients receiving infliximab and those treated with BOW015…”

Conference • P3 data • Biosimilar • Rheumatoid Arthritis

Data from Epirus’ phase 3 study of BOW015, a biosimilar infliximab, to be presented as a late breaking poster at the American College of Rheumatology Annual Meeting (Businesswire) - "EPIRUS Biopharmaceuticals...announced they will present data from their Phase 3 study, 'BOW015, a Biosimilar Infliximab, in Patients with Active Rheumatoid Arthritis on Stable Methotrexate Doses: 54-Week Results of a Randomized, Double-Blind, Active Comparator Study,' at the 2014 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP), November 18, in Boston, MA."

Conference • Biosimilar • Rheumatoid Arthritis

EPIRUS announces positive 58 week follow up data for BOW015 for treatment of rheumatoid arthritis (Epirus Press Release) - P3, N=189; "EPIRUS Biopharmaceuticals...announced positive 58 week follow up data from its BOW015 efficacy and safety trial comparing BOW015...The study met its primary endpoint of ACR20 response, the American College of Rheumatology criteria for clinical improvement in patients with rheumatoid arthritis, indicating a 20% improvement across a series of diagnostic parameters."

P3 data • Biosimilar • Rheumatoid Arthritis

A phase 3, randomized, double-blind, active comparator study of the efficacy and safety of BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis on stable methotrexate doses (EULAR 2014) - Presentation time: 11.06.2014, 18:15; Abstract #OP0012; P3, N=189; “The ACR20 responses at Wk 16 for BOW015 and iIFX, respectively, were 89.9% and 86.4% in the PP population (95% CI for the difference, -6.9% to 13.7%) and 85.0% and 85.5% in the intention-to-treat (ITT) population (95% CI for the difference, -11.2% to 10.3%)…Anti-IFX antibodies were detected in 22.1% of BOW015-treated and 35.5% of iIFX-treated subjects at Wk 14 (p=0.055). There was high concurrence between the BOW015-specific and iIFX-specific immunoassays among all subjects, regardless of treatment (κ=0.96).”

P3 data • Biosimilar • Rheumatoid Arthritis

Epirus: Corporate Overview (Epirus Biopharmaceuticals) - Anticipated global regulatory filings in H2 2017; Anticipated filings in South East Asia and Latin America in 2016

Anticipated non-US regulatory • Anticipated regulatory • Biosimilar

Epirus: Leerink Global Healthcare Conference (Epirus Biopharmaceuticals) - "BOW015 Demonstrated Biosimilarity to Remicade in Phase 1 and Phase 3 trials"

P1 data • Biosimilar

Epirus: Corporate Overview (Epirus Biopharmaceuticals) - Anticipated initiation of P3 global registration program by H2 2016; Anticipated global market filings in 2017

Anticipated new P3 trial • Anticipated regulatory • Biosimilar

Epirus and Ranbaxy announce signing of BOW015 licensing partnership for broad range of territories (Businesswire) - “EPIRUS Switzerland GmbH…and Ranbaxy Laboratories Limited…Tokyo, today announced the signing of a licensing agreement for BOW015, a biosimilar infliximab, for the broad range of territories including India, selected South East Asian markets, North Africa and several other markets…EPIRUS...in November, filed for market approval. Subsequent to launch in India, Ranbaxy will pursue registration and commercialization of BOW015 in other territories in South East Asia, North Africa and selected other markets.”

Licensing / partnership • Biosimilar • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

Epirus: Leerink Global Healthcare Conference (Epirus Biopharmaceuticals) - "58 Week Data - Patients can be Started and Maintained and Safely Switched From Remicade"; Open Label Phase - 58 weeks: Durability of response maintained out to 58 weeks with BOW015 alone and after switching from Remicade, BOW015 safe and well tolerated alone and after switching from Remicade, Consistent immunogenicity between arms: BOW015 alone and BOW015 switched from Remicade" 

P3 data • Biosimilar

Epirus Biopharmaceuticals announces positive phase 3 data supporting biosimilarity of BOW-015 to Remicade® (Business Wire) - P3, N=189; "BOW-015 achieved a week 16 ACR20 response rate of 89.8%, compared to 86.4% for Remicade. This outcome met its prespecified statistical endpoint and was within a 15% equivalence margin at a 95% confidence interval…First market authorization filing in Q4 2013.”

Anticipated regulatory • P3 data • Biosimilar • Rheumatoid Arthritis

Ranbaxy launches first biosimilar of infliximab drug in India (RTTNews) - “Ranbaxy Laboratories Ltd., India's largest pharmaceutical company, Monday launched Infimab, the first 'Remicade (Infliximab) biosimilar in India…The company said Infimab would be manufactured by Reliance Life Sciences at a facility in Mumbai.”

Biosimilar launch • Ankylosing Spondylitis • Biosimilar • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

Epirus: Leerink Global Healthcare Conference (Epirus Biopharmaceuticals) - Anticipated initiation of P3 trial for RA in Q4 2015/Q1 2016; Anticipated launch in multiple South East Asian markets throughout 2016; Anticipated regulatory submission in Indonesia, Mexico, Thailand, Korea, Argentina and Malaysia for RA in 2015

Anticipated launch non-US • Anticipated non-US regulatory • Anticipated trial initiation date • Biosimilar

The Experience With Biosimilars Of Infliximab In Rheumatic Diseases. (PubMed, Curr Pharm Des) - "Clinical data published so far have provided important evidence on long-term efficacy and safety, immunogenicity and switching, supporting the use of CT-P13 and SB2 for the treatment of rheumatic diseases. In addition, the European experience has proved the economic advantages of the incorporation of infliximab biosimilars in clinical practice. Despite the widespread use of infliximab biosimilars there is still a lack of data regarding interchangeability between reference products and biosimilars."

Journal

Researchers present real-world data on biosimilar infliximab agents at APLAR-ARA (Center for Biosimilars) - P=NA, N=199; "The drug retention rates of the biosimilar and reference were comparable (P = .8382), as were the retention rates of patients using infliximab in the first line or second line or greater." P=NA, N=149; "In total, 61.1% of patients had 4 doses of the drug, 6.7% had 3 doses, 24.8% had 2 doses, and 7.4% had 1 dose. Among the 81 patients with evaluable data, 91% had “major improvement,” 6% had “clinically important improvement,” and 3% did not respond adequately."

Clinical data