Holzkirchen, 25 February, 2016 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a type II variation for the addition of a subcutaneous (s.c.) route of administration in Binocrit’s® (epoetin alfa) nephrology indication*.
“Today’s CHMP positive opinion brings us one step closer to strengthening our epoetin alfa product offering which has already generated more than 400,0001 patient years of experience worldwide” said Carol Lynch, Global Head Biopharmaceuticals & Oncology Injectables, Sandoz. “If approved, the addition of the subcutaneous (s.c.) route of administration for use in our biosimilar Binocrit’s (epoetin alfa) nephrology indication will mean more choice for healthcare professionals as well as increased convenience for patients” Lynch continued.
The CHMP positive opinion was based on data from the SENSE clinical study an open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis patients.
The positive opinion is a formal recommendation by the CHMP to the European Commission which is applicable to all European Union and European Economic Area countries.
Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global market leader and currently markets three biosimilars. Sandoz has a leading pipeline amongst competitors and plans to make 10 regulatory filings over a three year period (2015-2017) having already submitted five. 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.
*Binocrit (epoetin alfa) is a prescription medicine that stimulates the bone marrow to produce red blood cells (anemia in either the nephrology or oncology setting).
For Binocrit’s approved indications and the EU summary of product characteristics including the labelled safety information please visit here.
The foregoing release contains forward-looking statements that can be identified by words such as “pipeline,” “momentum,” “sustained,” “planned,” “believes,” “proposed,” “seeking,” “long-term,” “strategy,” “priority,” “commitment,” “will,” “expected,” “committed,” “plans,” “well-positioned,” or similar terms, or by express or implied discussions regarding potential future revenues from biosimilar epoetin alfa. 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. These expectations 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 issues; unexpected manufacturing or quality 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.
Sandoz, a Novartis company, 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.
Periodic Safety Update Report, PSUR P7: Period until 31 Aug 2015, Date of Report: 22 Oct 2015.