Sandoz' biosimilar rituximab regulatory submission accepted by European Medicines Agency
May 24, 2016
Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year
Sandoz is seeking approval for all indications included in the reference product’s label
Sandoz’ submission includes data from multiple clinical trials with over 800 patients
Holzkirchen, 24 May, 2016 – Sandoz, a Novartis division and the global leader in biosimilars, announced today that the European Medicines Agency has accepted their Marketing Authorization Application for a biosimilar to Roche’s EU-licensed MabThera® (rituximab). Rituximab is a monoclonal antibody that is used to treat non-Hodgkin’s lymphoma, which includes follicular lymphoma and diffuse large B-cell lymphoma, chronic lymphocytic leukemia and autoimmune diseases such as rheumatoid arthritis. Sandoz is seeking approval for the same indications as the reference product.
"Patients with hematologic or blood cancers and rheumatoid arthritis, as well as their doctors, often have few treatment options and have long relied on rituximab as a vital part of their treatment," said Richard Francis, Division Head and CEO of Sandoz. "If approved, we believe our biosimilar rituximab will help broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines."
Sandoz believes that the totality of data in its submission will demonstrate that our biosimilar rituximab has essentially the same biological substance as, and the final drug product is highly similar to, the reference product. In addition to analytical, functional and pre-clinical data, the submission includes data from two pivotal confirmatory safety, PK/PD and efficacy studies that involved 629 follicular lymphoma and 173 rheumatoid arthritis patients.
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. Biosimilar rituximab is part of Sandoz’ growing oncology and immunology portfolios. The oncology portfolio includes two marketed products (filgrastim and epoetin-alfa) and biosimilar candidate pegfilgrastim, which is under regulatory review in the US and EU. Today’s announcement marks the sixth of 10 regulatory filings that the company plans to submit over a three-year period (2015-2017). 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.
The foregoing release contains forward-looking statements that can be identified by words such as "seeking," "believe," "will," "believes," "committed," "growing," "plans," "well-positioned," or similar terms, or by express or implied discussions regarding potential marketing approval for biosimilar rituximab, or potential marketing approvals for other products in the Sandoz biosimilar pipeline, or regarding potential future revenues from biosimilar rituximab or 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 rituximab will be approved for sale in any market, or at any particular time. Neither can there be any guarantee that, if approved, biosimilar rituximab will be approved for all indications included in the reference product’s 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 rituximab, or any other product in the Sandoz biosimilar portfolio, will be commercially successful in the future. In particular, management’s expectations regarding biosimilar rituximab 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 manufacturing, quality or safety 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 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 more than 1,000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.