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Biosimilar medicines were created to relieve cost burdens on the healthcare system.

And make critical treatments accessible to more patients.

Having more treatment options may in turn lead to more availability, more affordability, and more patients gaining access to biologic medicines.2

Disease areas in which biologic and biosimilar medicines are providing life-changing treatments2:

  • Lung Cancer
    Lung Cancer
  • Breast Cancer
    Breast Cancer
  • Diabetes
    Diabetes
  • Crohn's Disease
    Crohn's Disease
  • Hepatitis C
    Hepatitis C
  • Psoriasis
    Psoriasis
  • Kidney Disease
    Kidney Disease
  • Rheumatoid Arthritis
    Rheumatoid
    Arthritis
  • Hemophilia
    Hemophilia

And others

Progress for patients:
Europe leads the way.

EU

Biosimilars in the EU: Increased access

  • The first biosimilars were approved in the EU in 20063
  • More than 40 have been approved by the European Medicines Agency (EMA)3
  • Since 2006, patient treatment with biologics in the EU has increased by as much as 100%1
US

Biosimilars in the US: More challenging, but with huge potential

  • The first biosimilar in the US was approved in 20154
  • As biosimilar approvals continue to grow, litigation has slowed availability.4 However, rapidly changing policies and legislation are creating a mandate for change5,6
  • While the US healthcare system differs from that in the EU, the value of biosimilars in the US is seen as similarly promising1

As FDA’s public health mission strives to make innovative therapies accessible to patients and providers,6

Education, collaboration, and competition are helping biosimilars become an accepted part of the healthcare landscape.

In this evolving marketplace, Boehringer Ingelheim will continue to focus on making innovative biologics and biosimilars, helping to increase the availability of safe, effective, high-quality therapeutic options.7

References:
  1. 1. IMS Institute for Healthcare Informatics website. Delivering on the potential of biosimilar medicines: the role of functioning competitive markets. https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Institute-Biosimilar-Report-March-2016-FINAL.pdf. Accessed January 25, 2018.
  2. 2. Ryan AM. Frontiers in nonclinical drug development: biosimilars. Vet Pathol. 2015;52(2):419-426. https://www.bioxcellence.com/about_us/about_biotechnology/manufacturing_process_glance.html. Accessed June 27, 2018.
  3. 3. Generics and Biosimilars Initiative website. GaBI online. Biosimilars approved in Europe. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed June 22, 2018.
  4. 4. Siegel JF, Royzman I. US biosimilar approvals soar in 2017. Biologics Blog. https://www.biologicsblog.com/us-biosimilar-approvals-soar-in-2017. Accessed January 25, 2018.
  5. 5. Leiser M, Kahl K. Supreme Court ruling on biosimilars “a win” for patients. Healio website; HemOnc Today. https://www.healio.com/hematology-oncology/practice-management/news/print/hemonc-today/%7B0a7db11b-6539-47da-95c3-53bf0b9bff85%7D/supreme-court-ruling-on-biosimilars-a-win-for-patients. Accessed August 1, 2017.
  6. 6. Gottlieb S. Healthy innovation, safer families: FDA’s 2018 Strategic Policy Roadmap. United States Food and Drug Administration website. https://www.fda.gov/aboutfda/reportsmanualsforms/reports/ucm591993.htm. Accessed February 1, 2018.
  7. 7. Data on file. Ridgefield, CT: Boehringer Ingelheim Biopharmaceuticals, Inc.