Holzkirchen, 13 July, 2016. Sandoz, a Novartis assay and baton in biosimilars, appear today that the US Food and Drug Administration (FDA) Arthritis Advising Board recommended approval of its proposed biosimilar etanercept. The board voted absolutely (20-0), in abutment of biosimilar etanercept for all bristles break of the advertence product, including rheumatoid arthritis (RA), applique crawling (PsO), psoriatic crawling (PsA), ankylosing spondylitis (AS) and polyarticular adolescent idiopathic arthritis (JIA).
“We are encouraged by today`s favorable advising board advocacy for our proposed biosimilar etanercept,” said Mark McCamish, M.D., Ph.D., Head of All-around Biopharmaceutical Development, Sandoz. “As a all-around bazaar baton in biosimilars, we are admiring to move one footfall afterpiece against our ambition of accretion accommodating admission with our proposed biosimilar etanercept, and attending advanced to continuing to assignment with the FDA as they complete their assay of our application.”
The advocacy was provided afterwards the presentation of abstracts from a all-around development affairs including analytical, pre-clinical and analytic studies of the Sandoz biosimilar etanercept, which accustomed biosimilarity to the advertence product. Analytic studies included four allusive pharmacokinetic (PK) studies in 216 advantageous volunteers** and a acknowledging adeptness and assurance affinity abstraction in 531 patients with abiding applique psoriasis.
The FDA frequently seeks the admonition of its advising committees as it reviews and decides whether to accept applications, although the bureau does not consistently chase their recommendations.
In December 2015, the European Medicines Bureau (EMA) accustomed Sandoz Business Authorization Appliance (MAA) for its biosimilar to Amgen`s EU-licensed Enbrel®, which seeks approval for the aforementioned break as the advertence product.
Sandoz is committed to accouterment accommodating admission to high-quality, life-enhancing biosimilars. It is the avant-garde and all-around bazaar baton and currently markets three biosimilars worldwide. Sandoz has a arch activity with several biosimilars in backward date development, including assets in immunology and oncology. As allotment of the Novartis Group, Sandoz is well-positioned to advance the biosimilars industry based on its acquaintance and capabilities in development, accomplishment and commercialization.
About GP2015GP2015, the Sandoz proposed biosimilar of Enbrel®, has been advised in a all-around development program, which included a absolute allegory of GP2015 and Enbrel® at the analytical, non-clinical, and analytic levels, including abstracts from four pharmacokinetic (PK) studies (GP15-101, GP15-102, GP15-103 and GP15-104**) involving a absolute of 216 advantageous volunteers, as able-bodied as abstracts from a acknowledging adeptness and assurance abstraction of 531 patients with moderate-to-severe abiding applique crawling (PsO) (GP15-302). The development affairs additionally included bristles non-clinical studies. The proposed break for GP2015 are identical to the break for Enbrel® in rheumatoid arthritis (RA), PsO, psoriatic crawling (PsA), ankylosing spondylitis (AS) and polyarticular adolescent idiopathic arthritis (JIA).
DisclaimerThe above absolution contains advanced statements that can be articular by words such as “recommended,” “proposed,” “recommendation,” “encouraged,” “goal,” “look advanced to,” “committed,” “pipeline,” “late date development,” “well-positioned,” or agnate terms, or by accurate or adumbrated discussions apropos abeyant business approvals for biosimilar etanercept, or abeyant business approvals for added articles in the Sandoz biosimilar pipeline, or apropos abeyant approaching revenues from biosimilar etanercept and added articles in the Sandoz biosimilar portfolio. Such advanced statements reflect the accepted angle of the Group apropos approaching events, and absorb accepted and alien risks, uncertainties and added factors that may account absolute after-effects to be materially altered from any approaching after-effects bidding or adumbrated by such statements. There can be no agreement that biosimilar etanercept will be accustomed for auction in any bazaar breadth it has been submitted, or submitted for auction in any added markets, or at any accurate time. Neither can there be any agreement that, if approved, biosimilar etanercept will be accustomed for all break included in the advertence artefact label. Nor can there be any agreement that any added artefact in the Sandoz biosimilar activity will be submitted or accustomed for auction in any market, or at any accurate time. Neither can there be any agreement that biosimilar etanercept or any added artefact in the Sandoz biosimilar portfolio will be commercially acknowledged in the future. In particular, management`s expectations apropos biosimilar etanercept and such added biosimilar portfolio articles could be afflicted by, amid added things, abrupt authoritative accomplishments or delays or government adjustment generally; the uncertainties inherent in assay and development, including abrupt analytic balloon after-effects and added assay of absolute analytic data; antagonism in general; all-around trends against bloom affliction amount containment, including government, industry and accepted accessible appraisement pressures; abrupt action outcomes; abrupt safety, affection or accomplishment issues; accepted bread-and-er and industry conditions, and added risks and factors referred to in Novartis AG`s accepted Form 20-F on book with the US Securities and Exchange Commission. Novartis is accouterment the advice in this columnist absolution as of this date and does not undertake any obligation to amend any advanced statements independent in this columnist absolution as a aftereffect of new information, approaching contest or otherwise.
About SandozSandoz is a all-around baton in all-encompassing pharmaceuticals and biosimilars. As a assay of the Novartis Group, our purpose is to ascertain new means to advance and extend people`s lives. We accord to society`s adeptness to abutment growing healthcare needs by beat atypical approaches to advice bodies about the apple admission high- affection medicine. Our portfolio of added than 1000 molecules, accoutrement all above ameliorative areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our articles accomplished added than 500 actor patients and we aspire to adeptness one billion. Sandoz is headquartered in Holzkirchen, in Germany`s Greater Munich area.
* Enbrel® is a registered brand of Immunex Corporation.** GP15-104, one of the four PK studies that advised to authenticate bioequivalence amid GP2015 and EU-licensed Enbrel, was submitted as an alteration to the antecedent Biologics License Agreement at the appeal of European authorities
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The issuer of this advertisement warrants that they are alone amenable for the content, accurateness and dness of the advice independent therein.Source: Novartis International AG via GlobeNewswireHUG#2028522
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