The EGALITY study met its primary endpoint demonstrating equivalent efficacy of Sandoz biosimilar etanercept candidate to the originator product at week 12
As a first-of-its kind, the confirmatory clinical safety and efficacy study compares originator etanercept to a biosimilar candidate in psoriasis
Sandoz biosimilar etanercept has been accepted for review by the EMA* and FDA**
Holzkirchen, July 7, 2016 - Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced results from the EGALITY trial in which the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met. The study compared the safety and efficacy of its biosimilar etanercept candidate with the originator product, Enbrel®*** in patients with moderate-to-severe chronic plaque-type psoriasis and was presented at Psoriasis 2016, the 5th Congress of the Psoriasis International Network (PIN), Paris, France.
"The EGALITY data, showing our biosimilar etanercept to be bioequivalent to the originator product, is part of the comprehensive data package submitted to the EMA and FDA" said Malte Peters, Head Global Clinical Development, Biopharmaceuticals, Sandoz. "If our biosimilar etanercept is approved for the same indications as the originator product, more patients with chronic inflammatory conditions like rheumatoid arthritis and psoriasis will have access to life-changing biologic treatment options" Peters continued.
Additional data from the study confirms similarity between the biosimilar etanercept candidate and the originator product in terms of safety and immunogenicity; the incidence of adverse events at week 12 was comparable.
"The EGALITY study is a landmark in clinical trial design. Data has been collected from over 500 patients in one year with multiple treatment switches where a patient receives either the biosimilar etanercept candidate or the originator product on a number of alternate occasions," said Professor Diamant Thaçi, Comprehensive Center for Inflammation Medicine, University Medical School Schleswig-Holstein, Lubeck. "Data from this study, in addition to analytical, functional and pre-clinical studies, provides confidence in the comprehensive data package that is the basis for biosimilar medicine approval and use by healthcare practitioners." Thaçi continued.
Sandoz announced that its biosimilar etanercept candidate was accepted by the EMA and FDA for regulatory review in the second half of 2015. Sandoz is seeking approval for all indications included in the label of the originator product, which is used to treat various inflammatory conditions, including rheumatoid arthritis and psoriasis. Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars. Sandoz has a leading biosimilar pipeline and plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. This will be enabled by 11 filings over a three-year period (2015-2017) having already submitted six and had one approved. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.
About the EGALITY study (Psoriasis 2016, 5th Congress of the Psoriasis International Network (PIN) (PSO2016 ref: LATEABS-1325) The EGALITY study was a randomized, double-blind trial involving 531 patients and carried out in 74 dermatology clinics in 11 European countries and South Africa (NCT01891864). It compared the efficacy and safety of Sandoz etanercept biosimilar candidate with the originator product Enbrel®. The primary endpoint was equivalence in PASI 75 response rates after the first 12 weeks' treatment. Key secondary efficacy endpoints at week 12 were based on percent change from baseline in PASI, clinical safety and immunogenicity.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "candidate," "can," "confidence," "seeking approval," "committed," "pipeline," "plans," "launch," "will," "well-positioned," or similar terms, or by express or implied discussions regarding potential marketing approvals for biosimilar etanercept, or potential marketing approvals for other products in the Sandoz biosimilar pipeline, or regarding potential future revenues from biosimilar etanercept and other products in the Sandoz biosimilar portfolio. Such forward-looking statements reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results expressed or implied by such statements. There can be no guarantee that biosimilar etanercept will be approved for sale in any market where it has been submitted, or submitted for sale in any additional markets, or at any particular time. Neither can there be any guarantee that, if approved, biosimilar etanercept will be approved for all indications included in the reference product label. Nor can there be any guarantee that any other product in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that biosimilar etanercept or any other product in the Sandoz biosimilar portfolio will be commercially successful in the future. In particular, management's expectations regarding biosimilar etanercept and such other biosimilar portfolio products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; competition in general; global trends toward health care cost containment, including government, industry and general public pricing pressures; unexpected litigation outcomes; unexpected safety, quality or manufacturing issues; general economic and industry conditions, 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, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars, driving sustainable access to high-quality healthcare. Sandoz supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe. The Sandoz portfolio comprises approximately 1,100 molecules, which accounted for 2015 sales of USD 9.2 billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area. The company holds leading global positions in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines.
*European Medicines Agency (EMA) **US Food and Drug Administration (FDA) ***Enbrel® is a registered trademark of Pfizer in Europe and Amgen in the US.
Griffiths EM, et al. GP2015, a proposed etanercept biosimilar, has equivalent efficacy, safety and immunogenicity to etanercept originator product in patients with chronic plaque-type psoriasis: 12 week results from the phase 3 EGALITY study. Poster presented at the Psoriasis 2016, 5th Congress of the Psoriasis International Network (PIN), July 07, 2016 (e-poster P222)