24-week clinical study results confirm Erelzi™(etanercept-szzs) biosimilar matches efficacy and safety profile of reference medicine in patients with moderate-to-severe RA1
Erelzi was approved by the FDA in August 2016 for the treatment of immunological diseases including RA
Sandoz is the global leader in biosimilars, with five biosimilars approved worldwide – more than any other company2
Princeton, 4 November 2017– Sandoz, a Novartis division and the global leader in biosimilars, today announces results from the EQUIRA study1. The Phase III comparative safety and efficacy study shows that Sandoz biosimilar Erelzi™(etanercept-szzs) matches the reference medicine Enbrel®*, in terms of efficacy and safety profile in patients with moderate-to-severe rheumatoid arthritis (RA) and inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) over 24 weeks1. The results were presented at the American College of Rheumatology (ACR) Annual Meeting in San Diego, US.
"Approximately 1.3 million adults in the US are diagnosed with rheumatoid arthritis and its impact on the patient and the healthcare system is significant since rheumatic conditions are amongst the leading cause of disability in adults" 3, 4 said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. "These study results confirm findings from our initial development program demonstrating that Erelzi has the potential to expand access for patients with immunological diseases, including rheumatoid arthritis, and offers an important new biologic treatment option to healthcare professionals and payors."
The EQUIRA study is a randomized, double-blind Phase III confirmatory efficacy and safety study, which involved 326 patients with moderate-to-severe RA and an inadequate response to DMARDs. The primary endpoint was change from baseline in DAS28-CRP at week 24.
The study demonstrated that Erelzi matches the reference medicine in terms of efficacy and safety profile as measured by the mean change from baseline in DAS28-CRP, the ACR 20/50/70 response rates, and reported treatment-emergent adverse events1.
Erelzi was approved by the US Food and Drug Administration (FDA) in August 2016 and the European Commission (EC) in July 2017 for use in all indications of the reference medicine at the time of approval. These approvals were based on a comprehensive development program generating analytical, preclinical, and clinical data, including pharmacokinetic (PK) studies and a confirmatory clinical trial. Health Canada granted Erelzi a Notice of Compliance in April 2017, and the product has been launched. Erelzi received positive reimbursement recommendation from the Canadian Common Drug Review.
Sandoz is committed to increasing patient access to high-quality biosimilar medicines. As the global leader in biosimilar medicines, Sandoz has five biosimilar medicines currently marketed worldwide, as well as a leading global pipeline. Sandoz is well positioned to continue leading the biosimilar industry based on its experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, Sandoz benefits strongly from this unique blend of experience and expertise in many different market environments. 2
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ERELZI®? ERELZI is a medicine that affects your immune system. ERELZI can lower the ability of your immune system to fight infections. Serious infections have happened in patients taking ERELZI. These infections include tuberculosis (TB) and infections caused by viruses, bacteria or other opportunistic pathogens that have spread throughout the body. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Some patients have died from these infections. Your doctor should test you for TB before you take ERELZI and monitor you closely for TB before, during, and after ERELZI treatment, even if you have tested negative for TB. Treatment with ERELZI should not be initiated in patients with an active infection, including clinically important localized infections. Patients have frequently presented with disseminated rather than localized disease. There have been some cases of unusual cancers reported in children and teenage patients who started using tumor necrosis factor (TNF) blockers before 18 years of age. Also, for children, teenagers, and adults taking TNF blockers, including ERELZI, the chances of getting lymphoma, leukemia, melanoma, non-melanoma skin cancer or other cancers may increase. Patients with RA or psoriasis may be more likely to get lymphoma.
Before starting ERELZI, tell your doctor if you:
Have any existing medical conditions
Are taking any medicines, including herbals
Think you have, are being treated for, have signs of, or are prone to infection. You should not start taking ERELZI if you have any kind of infection, unless your doctor says it is okay
Have any open cuts or sores
Have diabetes, HIV, or a weak immune system
Have TB or have been in close contact with someone who has had TB
Were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure
Live, have lived in, or traveled to certain parts of the country (such as, the Ohio and Mississippi River valleys, or the Southwest) where there is a greater risk for certain kinds of fungal infections, such as histoplasmosis. These infections may develop or become more severe if you take ERELZI. If you don't know if these infections are common in the areas you've been to, ask your doctor
Have or have had hepatitis B
Have or have had heart failure
Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ERELZI
Use the medicine Kineret®** (anakinra), Orencia®+ (abatacept), or Cytoxan®+ (cyclophosphamide)
Are taking anti-diabetic medicines
Have, have had, or develop a serious nervous disorder, seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome
Are scheduled to have surgery
Have recently received or are scheduled for any vaccines
Are allergic to rubber or latex
Are pregnant, planning to become pregnant, or breastfeeding
Have been around someone with chicken pox
Have moderate to severe alcoholic hepatitis
What are the possible side effects of ERELZI? ERELZI can cause serious side effects including: New infections or worsening of infections you already have; hepatitis B can become active if you already have had it; nervous system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes; blood problems (some fatal); new or worsening heart failure; new or worsening psoriasis; allergic reactions; autoimmune reactions, including a lupus-like syndrome and autoimmune hepatitis. Live vaccines should not be given concurrently with ERELZI. It is recommended that pediatric patients, if possible, be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating ERELZI therapy. 3
Common side effects include: Injection site reactions, upper respiratory infections (sinus infections), and headache.
In a medical study of patients with JIA, side effects were generally similar in frequency and type as those seen in adult patients. The kinds of infections reported were generally mild and similar to those usually seen in children.
These are not all the side effects with ERELZI. Tell your doctor about any side effect that bothers you or does not go away.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see Prescribing Information and Medication Guide
Disclaimer 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 biosimilar 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 biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, 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.
About Sandoz Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales 4
of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.