Sandoz enters into commercialization agreement for biosimilar bevacizumab with Bio-Thera Solutions, Ltd., for treatment of multiple types of cancers1,2Sandoz is committed to building on its leading generic and biosimilar oncology portfolio to further expand patient access, while contributing to sustainability of healthcare systems
Bio-Thera Solutions, Ltd. will maintain responsibility for development and manufacturing,
This agreement builds on Sandoz’s leading off-patent oncology portfolio, which comprises four marketed oncology biosimilars and over 50 generic medicines worldwide3,4. We see external collaborations as complementary to our internal programs, with an appropriate strategic balance enabling us to drive patient access by delivering portfolio breadth, balancing risks and costs and positioning us to play a leading role in the future biosimilar market.
Bio-Thera Solutions, Ltd. is a biopharmaceutical company located in
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,” “may,” “could,” “would,” “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 biosimilar bevacizumab, or regarding the commercialiation agreement described in this press release, or regarding potential future revenues from biosimilar bevacizumab. 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 biosimilar bevacizumab 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, biosimilar bevacizumab will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that biosimilar bevacizumab will be commercially successful in the future. Neither can there be any guarantee that the commercialization agreement will achieve any or all of the anticipated outcomes for Novartis, or in any particular time frame. In particular, our expectations regarding biosimilar bevacizumab and the commercialization agreement 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 bevacizumab; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit
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References
- Avastin®, INN-bevacizumab -
European Medicines Agency . Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf. [Last accessed: August 2021]. European Medicines Agency . Summary of Product Characteristics. Available from https://www.ema.europa.eu/en/documents/overview/equidacent-epar-medicine-overview_en.pdf. [Last accessed: August 2021].Sandoz data on file.- IQVIA through 2020, definition excludes biosimilars
*Avastin® is a registered trademark of
** countries geographically in
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