Sandoz announces global deal to commercialize proposed biosimilar natalizumab, a key multiple sclerosis medicine

SandozSandoz, a Novartis division and a global leader in biosimilars, announced that it has entered into a global commercialization agreement for a proposed natalizumab biosimilar. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS).

RRMS affects ~85% of MS patients and can create a substantial social and economic burden on patients, their families and healthcare systems[1],[2]

Under the agreement, Polpharma Biologics will maintain responsibilities for development, manufacturing and supply of proposed biosimilar natalizumab. Sandoz will commercialize and distribute the medicine in all markets upon approval, through an exclusive global license. Other specific terms of the agreement are confidential. Polpharma Biologics is a European biopharmaceutical company with a fully integrated R&D and manufacturing footprint.

Reference medicine natalizumab is a disease-modifying therapy (DMT) that was approved for use over 10 years ago, offering patients a valuable therapeutic option for treating RRMS.

In addition to the personal burden of MS for patients and families, affordability is a significant challenge for MS medicines globally. A recent report highlighted affordability as the most common challenge affecting access to MS therapy in 46% of the 90 countries included[1]. Elsewhere it has been highlighted that providing access to DMTs for MS represents a considerable challenge for healthcare systems[3].

"Patient access to advanced medicines is important for all people diagnosed with a chronic disease, but the challenges are very pronounced for MS patients," said Pierre Bourdage, ad interim Global Head of Biopharmaceuticals, Sandoz. "By nature, biosimilars create competition and cost savings, which are proven to make room in healthcare systems to treat more patients[4]. With this agreement, we hope to build on our MS experience with small molecules and complex generics, and ultimately provide patients with expanded access to a DMT that healthcare systems may otherwise not be able to provide."

Sandoz continues to expand the biosimilars marketplace and is committed to help millions of patients access biologic medicines sustainably and affordably. The addition of proposed biosimilar natalizumab expands the Novartis/Sandoz portfolio across small molecules, complex generics, biosimilars, and innovator medicines enabling broad patient access to patented and off-patent medicines. In addition to entering complex and underserved areas such as MS, Sandoz is already helping patients in the areas of immunology, oncology and endocrinology. The division has a leading global portfolio with eight marketed biosimilars and a further 10+ in development.

About Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars, and a pioneer in the emerging field of prescription digital therapeutics. Our purpose is to pioneer access to healthcare by developing and commercializing novel, affordable approaches that address unmet medical need. Our broad portfolio of high-quality medicines, covering all major therapeutic areas and increasingly focused on value-adding differentiated medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

1. Multiple Sclerosis International Federation. The atlas of MS international report. Available from: http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf [Last accessed: June 2019].
2. Multiple Sclerosis International Federation. Global economic impact of multiple sclerosis, May 2010 [online]. Available from: https://www.msif.org/wp-content/uploads/2014/09/Global_economic_impact_o... [Last accessed: June 2019].
3. Brandstadter R, Sand IK. The use of natalizumab for multiple sclerosis. Neuropsychiatr Dis Treat 2017;13:1691-1702.
4. D'Amico E, et al. Pharmacoeconomics of synthetic therapies for multiple sclerosis. Expert Opin Pharmacother 2019:1-10.
5. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther 2012;91(3):405-417 (Figure 7).

Most Popular Now

AstraZeneca amends collaboration with Ironwood for…

AstraZeneca has amended its collaboration agreement with Ironwood Pharmaceuticals, Inc. (Ironwood) in China mainland, China Hong Kong and China Macau for Linzess (linaclo...

Cause of antibiotic resistance identified

Scientists have confirmed for the first time that bacteria can change form to avoid being detected by antibiotics in the human body. Studying samples from elderly patient...

Bayer, Brigham and Women’s Hospital, and Massachus…

Bayer and Partners HealthCare's founding members Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH) today announced the launch of a joint lab to ...

FDA grants Fast Track designation for Farxiga in h…

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk ...

Amgen announces positive results from two Phase 3 …

Amgen (NASDAQ:AMGN) today announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (2012021...

Brilinta monotherapy in high-bleeding risk patient…

New data from TWILIGHT, a Phase IV independent trial (funded by AstraZeneca), showed that in patients at high-bleeding risk who underwent PCI and completed 3 months of du...

Gene-targeted cancer drugs, slow release overcome …

Biomedical engineers at Duke University have developed a method to address failures in a promising anti-cancer drug, bringing together tools from genome engineering, prot...

Educational campaign helps teens and their caregiv…

Teenagers face many challenges, and growing up with a chronic skin disease called atopic dermatitis (AD) can impact the ups and downs and transitions to young adulthood. ...

Study points to new drug target in fight against c…

Researchers have identified a potential new drug target in the fight against cancer. In a study this week in the Proceedings of the National Academy of Sciences, an inter...

AstraZeneca divests rights for Losec to Cheplaphar…

AstraZeneca has agreed to sell the global commercial rights, excluding China, Japan, the US and Mexico, for Losec (omeprazole) and associated brands to Cheplapharm Arznei...

Cheaper drug just as effective protecting heart in…

A new clinical trial conducted at The Ohio State University Wexner Medical Center found a cost-effective generic medication works just as well as a more expensive drug in...

Dengue virus becoming resistant to vaccines and th…

Researchers from Duke-NUS Medical School (DukeNUS), in collaboration with the Agency for Science, Technology and Research (A*STAR)'s Bioinformatics Institute (BII), and t...