YAFI Online Programming // Disease State Management and Drug Therapy

Non‐Medical Switching

Biosimilars in Inflammatory Conditions 

Educational Objectives

After participating in this activity pharmacists will be able to:

  • Describe the FDA process for approval of biosimilars
  • Recognize key terminology of biosimilarity, interchangeability, totality of evidence, immunogenicity, extrapolation, and nocebo effect
  • Compare biosimilars and approved reference products in inflammation for formulary decisions, patient monitoring, and delivering education to other healthcare providers
  • Identify state pharmacy requirements for biosimilar substitution

After participating in this activity pharmacy technicians will be able to:

  • Compare the cost savings of biosimilars to reference biologic products in inflammatory conditions
  • Describe the difference between a biosimilar and a generic product
  • Determine when to refer patients to the pharmacists for recommendations or referrals

Session Offered

Release Date: January 15, 2021

Expiration Date: January 15, 2023

Course Fee

Free

Session Codes

21YC02-XXT33 Pharmacist

21YC02-TXK44 Pharmacy Technician

Accreditation Hours

2.0 hours of CE

Abstract

Although biologics were used by only 2% of the population in 2019, they constituted 48% of all drug spending. Biosimilars, which are are biosimilar to an FDA-approved reference product, have the potential to save money for health systems and patients. Patients may prioritize biologic therapy over their small molecule therapies for common asymptomatic diseases like hypertension and hyperlipidemia for financial reasons. Pharmacists and technicians who understand which biosimilars are available and applicable state and federal laws can alert patients or their prescribers of the existence of a lower cost biosimilar. They can also dispel myths and combat nocebo effect.

Accreditation Statements

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Pharmacists and pharmacy technicians are eligible to participate in this application-based activity and will receive up to 0.2 CEU (2 contact hours) for completing the activity, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor on- line system and your participation will be recorded with CPE Monitor within 72 hours of submission

ACPE UAN:
0009-0000-21-002-H01-P
0009-0000-21-002-H01-T

Grant funding: Pfizer

Cost: Free

Initial Release Date: January 15, 2021
Expiration Date: January 15, 2023

To obtain CPE credit, visit the UConn Online CE Center

Use your NABP E-profile ID and the session code 21YC02-XXT33 for pharmacists or 21YC02-TXK44 for pharmacy technicians to access the online quiz and evaluation.

First- time users must pre-register in the Online CE Center. Test results will be displayed immediately and your participation will be recorded with CPE Mon- itor within 72 hours of completing the requirements.

For questions concerning the online CPE activities, email joanne.nault@uconn.edu

Faculty

C. Michael White, Pharm.D., FCP, FCCP; Distinguished Professor and Head, Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs, CT and Director, HOPES Collaborative Group, University of Connecticut and Hartford Hospital, Hartford, CT.

Faculty Disclosure

The author has no actual or potential conflicts of interest associated with this article.

Disclosure of Discussions of Off-label and Investigational Drug Use

This activity may contain discussion of off label/unapproved use of drugs. The content and views presented in this educational program are those of the faculty and do not necessarily represent those of the University of Connecticut School of Pharmacy. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Content

Introduction

Most medications dispensed in the United States are small molecule drugs.1 They have simple structures with low molecular weights (e.g., ampicillin, atorvastatin, omeprazole, and ibuprofen). Aspirin, for example, is comprised of only 21 atoms.2 Small molecules are produced using simple chemical processes and it’s easy to make identical, stable copies called generics with which we are all familiar.3

Biologics (“Specialty Drugs”) are monoclonal antibodies, enzymes, or hormones comprised of polysaccharides, proteins, and nucleic acids.2,3 These chemical structures have high molecular weights as demonstrated by adalimumab, a biologic anti-inflammatory, containing 20,067 atoms.2 They have complex secondary and tertiary molecular folding structures and the existence or orientation of side groups that might be produced by one manufacturing process but not others.2,3

Research scientists genetically engineer living organisms or tissues to produce biologic products.3 They cultivate the most effective cell lines and then nurture them in strictly controlled environments to minimize variability. Skilled laboratory technicians then harvest, isolate, and purify the biologic entity from these cells/tissues. Specific cell lines are proprietary to the manufacturer (like a vineyard or a brewery having proprietary microorganism strains that give their products unique characteristics). The manufacturer also owns the growth conditions cells are exposed to. Given biologic products’ unique nature and their complexities, manufacturers who want to create exact copies of biologic products cannot do it unless they have access to the originator’s proprietary information (and they rarely do).3 As such, healthcare regulators cannot apply the Drug Price Competition and Patient Term Restoration Act of
1984 and no one can make generic versions of biologic products.4

Although biologic products were used by only 2% of the population in 2019, they constituted 48% of all drug spending.1 Biological drugs for inflammatory conditions like rheumatoid arthritis, psoriasis, and inflammatory bowel disease account for $187 of ‘drug spend’ per member per month in managed care organizations, by far the most-costly therapeutic class in 2019. Cancer spending was only $75 per member per month in 2019. Not only that; spending on inflammatory disorders rose 17% from the year before and the trend in 2020 was even greater.1 In total, biologic products have accounted for 93% of the increase in drug costs since 2014 in the US.1,2

References

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