Drug Types: Biosimilars, Generics, and More

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SPEAKER(S) Stevan Lalich, Pharm.D.

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Stevan Lalich has served in several clinical roles during his current 5-year tenure at CVS Health. In his current role, he focuses on developing and executing payer strategies specifically for the oncology therapy class. Prior to this current position Stevan served as the Oncology Clinical Therapy Manager on the Specialty Manufacturer Services Team, where his scope of responsibility focused on clinical oversight of the oncology drug therapy portfolio for the specialty business unit.

He also served as the oncology subject matter expert for the CVS Specialty Trade team for consultant RFP responses and manufacturer capabilities presentations in efforts to secure access to oncology pipeline assets. Stevan regularly provides oncology-related clinical therapy training across the organization to various audiences as needed including specialty pharmacy operations personnel and oncology prescriber team members.

Stevan obtained his Pharm.D. degree from the University of Illinois.

Review of Biosimilars

Stevan Lalich, PharmD

CVS Health

December 12, 2017

• Avastin

• Epogen

• Herceptin

• Humira

• Neulasta

• Remicade

• Rituxan

What Are Biologic Medicines?

• Large, complex molecules • Typically derived from living cells

• microorganism, plant cell, or animal cell

• Used in the treatment, diagnosis or prevention of disease

• Highly sensitive to manufacturing and handling conditions

• Almost always injectable• Can be specialty or non-specialty

1. “Biosimilar Competition in the United States: Statutory Incentives, Payers and Pharmacy Benefit Managers,” Health Affairs, February 2015. This slide contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Specialty.

Spending on U.S. biologics is expected to increase annually by more than 10 percent until key biosimilars are launched.1

EXAMPLES OF SPECIALTY BIOLOGICS

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Comparison of Traditional Small Molecule Drugs and Biologic Agents

NDA (New Drug Application). ANDA (Abbreviated New Drug Application). BLA (Biologics License Applications). Source: Special Report: Understanding Key Difference Between Biosimilars and Small Molecule Generics, McMahon Publishing, May 2013.

FEATURES SMALL MOLECULE DRUGS BIOLOGIC AGENTS

EXAMPLE Aspirin (180 Da) Avastin (Monoclonal antibody) (~150,000 Da)

ENTITY Chemical Protein

STRUCTURE Small, simple, well characterized Large, complex, heterogeneous

STABILITY Stable Unstable

MODE OF ADMINISTRATION Usually amenable to ingestion Usually requires injection or infusion

MANUFACTURING PROCESSPredictable and precise method; identical copies in batches

Living cell-based complex technology; batch-to-batch variation, sensitive to storage and handling

IMMUNOGENICITY Mostly non-immunogenic Immunogenic

APPROVAL PROCESS NDA (Generics = ANDA) BLA (Follow on biologics = BPCIA)

Unlike small molecule generic drugs, biologics cannot be exactly replicated.

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“Small molecule” Drugs vs Biologics

(Bicycle vs F-16 Fighter Jet Analogy)

• Biological products are generally produced using a living system or organism

• Biological products may be manufactured through biotechnology, derived from natural sources, or produced synthetically

What is a biosimilar product?

• A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic reference product.

• Small molecule drugs (like oral blood pressure pills) have generics

• Biologics (like Avastin) have biosimilars

• Biosimilars are NOT generics and thus are not directly substitutable at the pharmacy (more details to come on this topic……)

Example of clinically insignificant differences

Biosimilar and Innovator Development

Source: www.biosimilarsresourcecenter.org. How Does a Manufacturer Demonstrate Biosimilarity? https://www.biosimilarsresourcecenter.org/faq/how-does-a-manufacturer-demonstrate-biosimilarity/, accessed October 11, 2017. Biosimilarity at each step provides totality of evidence and scientific justification for extrapolation.

INNOVATOR BIOLOGIC APPLICATION BIOSIMILAR APPLICATION

ADDITIONAL CLINICAL STUDIES

CLINICAL PHARMACOLOGY

NON-CLINICAL

ANALYTICAL

CLINICAL STUDIES

CLINICAL PHARMACOLOGY

NON-CLINICAL

ANALYTICAL

EXTENSIVE CLINICAL PROGRAM TARGETED CLINICAL PROGRAM

351(k) application – demonstrate biosimilarity to its innovator product

351(a) application – demonstrate safety, purity and potency

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What is an interchangeable product?

• An interchangeable product is a biosimilar product that meets additional requirements outlined by the Biologics Price Competition and Innovation Act. As part of fulfilling these additional requirements, information is needed to show that an interchangeable product is expected to produce the same clinical result as the reference product in any given patient. Also, for products administered to a patient more than once, the risk in terms of safety and reduced efficacy of switching back and forth between an interchangeable product and a reference product will have been evaluated.

• An interchangeable product may be substituted for the reference product without the involvement of the prescriber. FDA’s high standards for approval should assure health care providers that they can be confident in the safety and effectiveness of an interchangeable product, just as they would be for an FDA-approved reference product.

INTERCHANGEABLE BIOLOGICAL PRODUCT

• Biosimilar to the FDA-approved reference product

• Meets additional standards for interchangeability

• May be substituted for the reference product by a pharmacist without intervention by prescribing provider

BIOSIMILAR PRODUCT

BPCIA, Part of the Affordable Care Act, Created an Abbreviated Licensure Pathway for Biosimilars

Biosimilarity does not imply interchangeability

BPCI Act (Biologics Price Competition and Innovation Act of 2009).Source: http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm, accessed November 16, 2017.

• Biological product

• Highly similar to the FDA-approved biological “reference” product

• No clinically meaningful differences in safety and effectiveness

• Only minor differences in clinically inactive components allowable

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Are biosimilars the same as generic drugs?

• Biosimilars and generic drugs are versions of brand name drugs and may offer more affordable treatment options to patients. Biosimilars and generics are each approved through different abbreviated pathways that avoid duplicating costly clinical trials. But biosimilars are not generics, and there are important differences between biosimilars and generic drugs.

• For example, the active ingredients of generic drugs are the same as those of brand name drugs. In addition, the manufacturer of a generic drug must demonstrate that the generic is bioequivalent to the brand name drug.

• By contrast, biosimilar manufacturers must demonstrate that the biosimilar is highly similar to the reference product, except for minor differences in clinically inactive components. Biosimilar manufacturers must also demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety and effectiveness.

Adalimumab-atto

Biosimilars FDA Naming Convention

Etanercept-szzs

Core name FDA-designated suffix

No recognizable meaning

4 letters

Lowercase

Filgrastim-sndz

Infliximab-abda

Bevacizumb-awwb

Infliximab-dyyb

Adalimumab-adbm

FDA. Nonproprietary naming of biological products: guidance for industry. 2017.

FDA-Approved Biosimilar Products

FDA approval does not necessarily mean commercially available due to existing drug patents still in place.

Impact of Biosimilars to the Marketplace

• Creates more competition

• More competition should lead to lower drug prices• To date we have seen a varying range of pricing discounts for biosimilar drugs

• Health plans are continuing to explore how to maximize the value of biosimilars to make these expensive therapies more affordable

• Example: Insurance may block brand reference product and only cover the biosimilar

• Adoption in the U.S. has been fairly low to date• Largely due to physician and patient uncertainty about biosimilars, thus often

electing to use the reference brand product

• In comparison, much of Europe has strongly adopted biosimilars use

FDA Information on Biosimilars

• https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/

Drug Label Information Overview

Reading a manufacturer’s prescribing information document (aka package insert)

• Suggest reviewing initial section often titled “Highlights of Prescribing Information” which provides a concise, one-half page summary of information in the Full Prescribing Information

• Provides quick summary of most important information including:

• Black box warnings

• Indications and usage

• Dosing and administration

• Available dosage forms

• Contraindications

• Warnings and precautions

• Adverse reactions

• Use in special populations (e.g, pregnancy, kidney or liver issues)

• For specific areas of interest, go to that specific section of the package insert for more detailed information

FDA Prescribing Information Website

• https://dailymed.nlm.nih.gov

• Electronic, user-friendly format

• All FDA approved drugs available for review on this website

• Includes images of drug packaging

How to Read a Prescription Label

Questions about Prescription Drug Therapy

What to do if you have questions about your medication?

• If an emergency situation, always contact your doctor or call 911 first

• If non-emergency, such as wondering if mild persistent nausea or diarrhea is caused by your drug therapy, call your pharmacy and ask to speak directly to the pharmacist

• If you are taking a medication that is mailed to you from a specialty pharmacy, contact the specialty pharmacy versus your local retail pharmacy as they likely will be more knowledgeable in that area (most notably cancer)

• Common questions that the specialty pharmacist commonly receives:• “Is this a side effect of my drug that I am experiencing?”

• “If so, what can I do to address?”

• “Is there available financial support?”

• They can help find manufacturer copay assistance and/or foundation support

• “I’m not feeling any better/different, is my medication working?“• Important to remain adherent, may be that drug is keeping condition in check and not getting

worse which is a successful outcome. Make sure you are getting routine lab checks (like blood tests) and MD visits (physical exams) to monitor true response to therapy

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