Holzkirchen, November 12, 2019 - Sandoz, a Novartis division and a global leader in biosimilars, presented an interim analysis (abstract number 553) from the COMPACT study on real-world treatment of rheumatic disease patients with biosimilar Erelzi® (etanercept-szzs) at the 2019 American College of Rheumatology and Association of Rheumatology Professionals (ACR/ARP) Annual Meeting in Atlanta, Georgia. US analysis of long-term financial impact when switching to biosimilar etanercept modeling significant cost savings for health systems was also presented.
Patients with rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and ankylosing spondylitis (AS) were included in the COMPACT analysis that showed initial results of effectiveness and safety. For RA patients, improvements in effectiveness and functional disability were shown. No new safety signals were observed compared to previously published data on etanercept.
COMPACT is an ongoing observational study of treatment of RA, PsA and AS patients with Erelzi. In total, 430 patients were recruited in Germany, United Kingdom, Spain, Poland, and Canada. The interim analysis reports out initial effectiveness data for the RA patient subgroup, as well as safety data for all enrolled patients at Week 12.
"If untreated, rheumatoid arthritis can have a devastating impact on patients, with at least 50 percent of people in developed countries unable to hold down a full-time job within ten years of onset," said Florian Bieber, Global Head of Development, Sandoz Biopharmaceuticals. "Interim data from the COMPACT study, along with long-term US cost savings modeling analysis, help build confidence in the value of biosimilars, which may enable more patients to access advanced biologic medicines earlier and offer significant savings for overburdened health systems."
"The interim analysis from the COMPACT study adds evidence to a growing body of research that confirms the safety and efficacy of biosimilar etanercept," said COMPACT study investigator Dr. Marc Schmalzing, Deputy Head and Senior Physician of the Department of Rheumatology/Clinical Immunology, University of Wurzburg. "In addition to the existing clinical research on Erelzi, we now can see how this biosimilar is performing in a real-world patient population setting with comorbidities and concomitant medications."
In addition to the COMPACT analysis, results from a US economic model (abstract number 251) were presented by Sandoz. Investigators evaluated the economic impact of switching patients from a reference etanercept to a biosimilar in patients with rheumatic diseases in the US, taking into consideration the upfront costs when implementing a formulary change. Results demonstrated that despite the early, administrative costs associated with managing the formulary process, substantial cost savings can be realized by integrated delivery networks (IDNs) when transitioning patients to the biosimilar. For IDNs with low administrative costs, the total potential pharmacy cost savings were shown to be $62.4 million over five years, assuming that up to 1,331 patients per year are treated with etanercept across all three indications.
"This model shows that substantial pharmacy cost savings, about $10,000 per switched patient per year, far outweighed the relatively minor incremental administrative and labor costs associated with implementation of a formulary change," said Edward Li, Author and Associate Director, Health Economics and Outcomes Research (HEOR)
By actively investing in the future of biosimilars, Sandoz expects to continue to lead the marketplace and deliver on its promise to help millions of patients in immunology, oncology, endocrinology and other underserved therapy areas access biologic medicines sustainably and affordably.
 Schmalzing M, Askari A, Walsh D. Etanercept Biosimilar GP2015 (Erelzi®) in Rheumatic Diseases: Interim Analysis of Real-World data from COMPACT: A multicentric, prospective, observational cohort study. Presented at the 2019 ACR/ARP Annual Meeting. November 10, 2019.
 Data on file.
 Mezzio D, Li E, Balu S. Long-Term Financial Impact of Switching From Reference to Biosimilar Etanercept When Considering Short-Term Formulary Management Costs in the US. Presented at the 2019 ACR/ARP Annual Meeting. November 10, 2019.
Erelzi is the Sandoz biosimilar of the reference medicine, Enbrel®. Erelzi has been studied in a global development program, which included a comprehensive comparison of Erelzi and Enbrel® at the analytical, preclinical, and clinical levels.
Erelzi® IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ERELZI?
ERELZI may cause serious side effects, including:
1. Risk of Infection
2. Risk of Cancer
1. Risk of Infection
ERELZI can lower the ability of your immune system to fight infections. Some people have serious infections while taking etanercept products. These infections include tuberculosis (TB), and infections caused by viruses, fungi, or bacteria that spread throughout their body. Some people have died from these infections.
You should not start taking ERELZI if you have any kind of infection unless your healthcare provider says it is okay.
2. Risk of Cancer
Before starting ERELZI, be sure to talk to your healthcare provider:
ERELZI may not be right for you. Before starting ERELZI, tell your healthcare provider about all of your medical conditions, including:
Infections. Tell your healthcare provider if you:
Also, before starting ERELZI, tell your healthcare provider:
Keep a list of all your medications with you to show your healthcare provider and pharmacist each time you get a new medicine. Ask your healthcare provider if you are not sure if your medicine is one listed above.
Other important medical information you should tell your healthcare provider before starting ERELZI, includes if you:
What are the possible side effects of ERELZI?
ERELZI can cause serious side effects including:
Infections. ERELZI can make you more likely to get infections or make any infection that you have worse. Call your healthcare provider right away if you have any symptoms of an infection. See "Before starting ERELZI, be sure to talk to your healthcare provider" for a list of symptoms of infection.
Common side effects of ERELZI include:
These are not all the side effects with ERELZI. Tell your healthcare provider about any side effect that bothers you or does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Rheumatoid Arthritis: ERELZI 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). ERELZI can be initiated in combination with methotrexate (MTX) or used alone.
Polyarticular Juvenile Idiopathic Arthritis: ERELZI 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: ERELZI 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). ERELZI can be used with or without methotrexate.
Ankylosing Spondylitis: ERELZI is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).
Plaque Psoriasis: ERELZI is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
See more at: https://www.ERELZI.com
Click here for fullprescribing information.
Erelzi® is a registered trademark of Novartis AG
Enbrel® is a registered trademark of WYETH LLC/Immunex Corporation.
Kineret® is a registered trademark of Amgen Inc.
Orencia® is a registered trademark of Bristol-Myers Squibb Company.
Cytoxan® is a registered trademark of E.R. Squibb & Sons, L.L.C/ Bristol-Myers Squibb Company.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such biosimilar products will be approved for all indications included in the reference product's label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world's leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.
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