Sandoz Biosimilar Pipeline

Sandoz, a Novartis division, has a leading biosimilar pipeline and plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020.

Pipeline

Project/
Compound		 Potential indication/
Disease area		 Submission
status		 Milestones

GP2015
(etanercept)

 Arthritides (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), plaque psoriasis and others (same as reference product) US: approved
EU: submitted
  • Positive CHMP opinion
LA-EP2006 (pegfilgrastim) Chemotherapy-induced neutropenia and others (same as reference product) Phase III
  • Resubmission planned for 2018 to address FDA complete response letter
  • Withdrawal of EU filing in January 2017 with planned re-filing in 2017

HX575
(epoetin alfa)

 Chronic kidney disease, chemotherapy-induced anemia and others (same as reference product) Phase III
  • Trial complete
GP2013 (rituximab) Follicular lymphoma, diffuse large B cell lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiites, and microscopic polyangiites (same as reference product) US: Phase III
EU: submitted
  • Positive CHMP opinion
GP2017 (adalimumab) Arthritides (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), plaque psoriasis and others (same as reference product) Phase III
  • Recruitment in Phase III psoriasis study completed in Feb. 2015
GP2018 (infliximab) Autoimmune diseases including rheumatoid arthritis and psoriasis (same as reference product) Phase I  
GP1111 (infliximab) Autoimmune diseases including rheumatoid arthritis and psoriasis (same as reference product) Phase III  

Immunology

Immune system disorders affect hundreds of millions of people worldwide and can severely impact quality of life and even life expectancy1,2,3. These debilitating disorders include those affecting the joints (such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis), the skin (such as psoriasis) and the gut (such as Crohn’s disease and ulcerative colitis).

Sandoz is the long-term partner supporting rheumatologists, dermatologists and gastroenterologists in advancing patient care without compromise. Our proven expertise and experience in biosimilars, provides high-quality affordable medicines in this therapy area.  

We are committed to providing life-changing immunology therapies and have a robust portfolio of investigational biosimilars for these conditions including etanercept*, adalimumab, infliximab and rituximab.

Learn more about the wider Novartis Group’s involvement in immunology

  1. Gibofsky A. Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. Am J Manag Care. 2012 Dec;18(13 Suppl):S295-302.
  2. World Health Organization. Global report on psoriasis 2016. Available at: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf (link is external) (Accessed October 2016)
  3. Gladman D et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005;64:ii14-ii17 doi:10.1136/ard.2004.032482

*Erelzi® (etanercept) was approved in the US in August 2016

Oncology

Cancer is one of the leading causes of death and places a significant and growing burden on healthcare systems around the world1.

Sandoz is committed to increasing physician and patient access to broader options for quality cancer treatments that make up the foundation of cancer care. Biosimilar treatment options could free up resources, which can be redeployed for innovation, access and new interventions within healthcare systems to support and manage the burden of oncology care.

We currently market Zarzio® / Zarxio® and Binocrit®, both used in supportive cancer care. Sandoz also has a robust portfolio of investigational oncology biosimilars it is bringing to market, including rituximab and pegfilgrastim.

In addition to biosimilars, Sandoz has a broad portfolio of oral and injectable oncology medicines available around the world. Our early-stage pipeline includes additional assets in oncology as well as other specialty therapeutic areas with plans to start new programs every year.

With the combined strength and backing of Novartis, Sandoz is a long-term partner for oncology patients and oncologists.

Learn more about Novartis in oncology

  1. World Health Organization. World Cancer Report 2014. Available at: http://www.who.int/mediacentre/factsheets/fs297/en/ (link is external) (Accessed October 2016)

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