Adopting Biosimilars With ConfidenceAdopting Biosimilars With Confidence

ADOPTING

BIOSIMILARS

WITH CONFIDENCE

“Our ability to build a market for…biosimilar products is key for patients and our nation’s health care system.”1 – Scott Gottlieb, Former FDA Commissioner

A BIOEVOLUTIONARY OPPORTUNITY

For biosimilars to fulfill their potential to reduce the cost of biologic medicines, it will take the collective efforts of individual institutions and pharmacy directors leading the way through the adoption of biosimilars into their formularies.

More biosimilars are being developed every year

Biosimilar Product Development Programs Registered With the FDA (by fiscal year)2,3

BIOFUNDAMENTALS

Based on a foundation of science

Biosimilars Are Put Through Rigorous Development and Testing

Biosimilars are put through rigorous development and testing4

“All FDA-approved biological products, including reference products and biosimilar products, undergo a rigorous evaluation.”4 – FDA

Before applying to and receiving approval from the FDA, a biosimilar product must show that it has no clinically meaningful differences in safety, purity, and potency compared with the reference biologic. This is done through a stepwise approach:

Detailed Analytical Studies4

Demonstrate the 'Highly Similar' Nature of a Biosimilar Product to the Reference BiologicDemonstrate the 'Highly Similar' Nature of a Biosimilar Product to the Reference Biologic
  • To identify and compare structural and functional characteristics and to demonstrate the “highly similar” nature of a biosimilar product to the reference biologic
 

Comparative Clinical Studies (if necessary)4

Confirm Biosimilarity of the Product in Patients in at Least One Approved Indication of the Reference BiologicConfirm Biosimilarity of the Product in Patients in at Least One Approved Indication of the Reference Biologic
  • To confirm biosimilarity of the product in patients in at least one approved indication of the reference biologic

BIOLEADERSHIP

Spearheading institutional implementation

What to consider for biosimilar organizational adoption

What to Consider for Biosimilar Organizational AdoptionWhat to Consider for Biosimilar Organizational Adoption

Before adding any medicine onto formulary, nearly every organization relies on its pharmacy and therapeutics (P&T) committee to conduct a broad and detailed evaluation of the product, including biosimilars.

Key elements of biosimilar formulary review:

Clinical Parameters5

Clinical Parameters: Key Element of Biosimilar Formulary ReviewClinical Parameters: Key Element of Biosimilar Formulary Review
  • Indications
  • Clinical data
  • Immunogenicity

Product Characteristics5

Product Characteristics: Key Element of Biosimilar Formulary ReviewProduct Characteristics: Key Element of Biosimilar Formulary Review
  • Nomenclature
  • Supply chain
  • Packaging/Labeling

Institutional Considerations5

Institutional Considerations: Key Element of Biosimilar Formulary ReviewInstitutional Considerations: Key Element of Biosimilar Formulary Review
  • Cost/Reimbursement
  • Pharmacovigilance
  • Patient/Provider education
  • Tracking and information system implications
Biosimilars May Offer Health Care System Benefits

Biosimilars may offer health care system benefits1,6

Increased Competition
  • Increased competition
Reduced Cost for Payers
  • Reduced cost for payers

BIOCOLLABORATIVE

Partnering for today and the future

At Merck, our Core Values - Patients First, Ethics and Integrity - Reflect this Belief and Guide Everything we Do, Including our Approach to BiosimilarsAt Merck, our Core Values - Patients First, Ethics and Integrity - Reflect this Belief and Guide Everything we Do, Including our Approach to Biosimilars

At Merck, we believe that lasting partnerships based on mutual respect and accountability are beneficial to finding solutions that will result in better health outcomes and lower costs. Our core values—patients first, ethics, and integrity—reflect this belief and guide everything we do, including our approach to biosimilars.

References: 1. US Department of Health and Human Services, Food and Drug Administration. Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s biosimilars action plan. https://www.fda.gov/news-events/press-announcements/remarks-fda-commissioner-scott-gottlieb-md-prepared-delivery-brookings-institution-release-fdas. Published July 18, 2018. Accessed May 19, 2020. 2. Jenkins J. Office of New Drugs, Center for Drug Evaluation and Research. Biosimilars in the US: Progress and Promise, DIA Biosimilars 2016. https://wayback.archive-it.org/7993/20170405202142/https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM526935.pdf. Published October 27, 2016. Accessed May 19, 2020. 3. US Department of Health and Human Services, Food and Drug Administration. Cumulative number of biosimilar development programs in the BPD Program in the month. https://accessdata-preprod.fda.gov/scripts/FDATrack/view/track.cfm?program=cder&id=CDER-RRDS-Number-of-biosimilar-dev-programs-in-BPD-Program. Accessed May 19, 2020. 4. US Department of Health and Human Services, Food and Drug Administration. Biosimilar development, review, and approval. https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval. Published October 20, 2017. Accessed May 6, 2019. 5. Ventola CL. Evaluation of biosimilars for formulary inclusion: factors for consideration by P&T committees. P&T. 2015;40(10):680–689. 6. Biosimilars Action Plan: Balancing Innovation and Competition. US Food and Drug Administration: Silver Spring, MD; 2018. https://www.fda.gov/media/114574/download. Published July 18, 2018. Accessed May 14, 2019.