Click or
tap here
to read our
newsletter
Keeping the promise of biologics

What is the promise of biologic medicines?

Cutting-edge medical treatments.

Biologic medicines are innovative, large-molecule therapies that effectively target specific diseases.1,2 However, the complexity of these medicines makes them expensive to produce, and their high price has placed a huge burden on patients, physicians, and the healthcare system. This led to the creation of the BPCIA (Biologics Price Competition and Innovation Act) of 2009 to encourage competition between manufacturers to develop biosimilar medicines—equivalent treatments on a shorter, less expensive approval pathway.2

Biosimilars, with safety and efficacy equivalent to already-approved biologics3 at a lower cost, have the potential to make biologic medicines more affordable, and thereby more accessible, to more patients.4

FACT: In 2015, while only 1% to 2% of the US population was treated with specialty drugs (which include biologics), the cost of biologics alone represented 38% of all US prescription drug spending.5

The RAND Corporation has projected that the use of biosimilar medicines in the US will reduce direct spending on biologics by $54 billion from 2017 to 2026.5

What is a biosimilar?

A highly similar version of an FDA-approved biologic medicine.6 It is produced using the same amino acid sequence as the reference biologic,6 has the same mechanism of action,4 and is proven to have no clinically meaningful differences from its reference biologic in safety, potency, and purity.2,4

What can biosimilars offer?

By reducing costs, biosimilars increase the availability of biologic medicines to people who need them for chronic or life-threatening diseases.4

How do biologic and biosimilar medicines compare to traditional medicines?

How do biologic and biosimilar medicines compare to traditional medicines?
How do biologic and biosimilar medicines compare to traditional medicines?

Keep in mind: Because biologics are cultured in living cells, natural variations are normal and expected, even between batches of the same biologic made in the same facility.9

Biologics have transformed the lives of millions.6 By reducing costs, biosimilars may transform the lives of millions more.4

Biologic and biosimilar medicines provide life-changing treatments for many diseases, including10,11:

Cancers
(eg, lung, breast,
and others)
Rheumatoid
arthritis
Plaque
psoriasis
Crohn's
disease

Boehringer Ingelheim: Founded in 1885,12
and a trusted biologics manufacturer since 1983.13

  • We are trusted by 15 of the top 20 pharmaceutical companies to manufacture their biologic medicines14
  • We have manufactured 29 biologics to date; 3 of them are among the most-prescribed biologic medicines in the world today14

We're proud to leverage our biologics manufacturing experience to develop biosimilar medicines that will help provide high-quality, safe, and effective treatment options for patients.

Sign up for biosimilar updates by email

Get insider news, keep up with regulatory information, hear from thought leaders and peers

Snapshot: View web conversations by category

Snapshot: View web conversations by category Snapshot: View web conversations by category

See what regulators, opinion leaders, and stakeholders are talking about

View newsletter

Biosimilar means…

Quality

Exacting standards and tight specifications are followed at every stage.

Proven Efficacy

The data package required is extensive.

Experience

It takes knowledge, infrastructure, and precision.

Choice

The fortunate result of collaboration and competition.

Sustainability

How legislation and policy are encouraging change.

Collaboration

By reaching out, we all reach higher.

More Than Molecules

The end goal is the patient experience.

References:
  1. 1. US Food and Drug Administration. What are “biologics” questions and answers. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm. Accessed May 10, 2018.
  2. 2. Blackstone EA, Fuhr JP Jr. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469-478.
  3. 3. Cohen SB, Alonso-Ruiz A, Klimiuk PA, et al. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomized VOLTAIRE-RA equivalence study. Ann Rheum Dis. 2018;77:914-921.
  4. 4. Rugo HS, Linton KM, Cervi P, Rosenberg JA, Jacobs I. A clinician's guide to biosimilars in oncology. Cancer Treat Rev. 2016;46:73-79.
  5. 5. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. RAND Corporation. https://www.rand.org/pubs/perspectives/PE264.html. Accessed January 5, 2018.
  6. 6. Ryan AM. Frontiers in nonclinical drug development: biosimilars. Vet Pathol. 2015;52(2):419-426.
  7. 7. Generics and Biosimilars Initiative. GaBI online. Small molecule versus biological drugs. http://www.gabionline.net/Biosimilars/Research/Small-molecule-versus-biological-drugs. Accessed March 23, 2018.
  8. 8. Zezza D, Seamon K, Garnick R, et al. Biologics: can there be abbreviated applications, generics, or follow-on products? BioPharm Intl. 2003;16(7):1-6.
  9. 9. US Food and Drug Administration website. Biosimilar and interchangeable products. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm. Accessed May 14, 2018.
  10. 10. Bridges SL Jr, White DW, Worthing AB, et al. The science behind biosimilars: entering a new era of biologic therapy. Arthritis Rheumatol. 2018;70(3)334-344.
  11. 11. Zelenetz AD, Ahmed I, Braud EL, et al. NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Canc Netw. 2011;9(suppl 4):S1-S22.
  12. 12. Boehringer Ingelheim Pharmaceuticals, Inc, website. Who we are. History. https://www.boehringer-ingelheim.com/who-we-are/history. Accessed May 15, 2018.
  13. 13. Boehringer Ingelheim Pharmaceuticals, Inc, website. Milestones of Boehringer Ingelheim’s biopharmaceutical business. History. https://www.boehringer-ingelheim.com/contract-manufacturing/biopharma/history-boehringer-ingelheims-biopharmaceutical-business? Accessed July 13, 2018.
  14. 14. Data on file. Ridgefield, CT: Boehringer Ingelheim Biopharmaceuticals, Inc.