Download Free Medical Biosimilar and Interchangeable Biological Products PowerPoint Presentation

Biosimilar and Interchangeable Biological Products PowerPoint Presentation

DOWNLOAD MEDICAL POWERPOINT PRESENTATION

About This Presentation

Description : Check out this medical PowerPoint presentation titled "Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources".

This medical PowerPoint presentation is about biosimilar and interchangeable biological products, two types of biological products that have emerged as alternatives to branded biologic drugs.

A biosimilar is a biological product that is highly similar to an already approved biological product (reference product) in terms of structure, function, and clinical effectiveness. The biosimilar is produced using a different manufacturing process, but it is expected to have the same clinical effect as the reference product. Biosimilars undergo extensive testing and evaluation to ensure that they are safe and effective before they can be approved for use.

An interchangeable biological product, on the other hand, is a biosimilar that has been demonstrated to be therapeutically equivalent to the reference product in all respects, including safety and efficacy, and can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. The interchangeable biological product must also meet additional standards for interchangeability, including the absence of increased risks of safety or diminished effectiveness when switching between the interchangeable product and the reference product.

Both biosimilars and interchangeable biological products offer patients a more affordable option than the branded biologic drugs, as they are often priced lower than the reference product. However, its important to note that biosimilars and interchangeable biological products are not identical to the reference product and may have some differences in efficacy and safety profiles. Therefore, its important for healthcare providers to carefully evaluate the suitability of these products for their patients and to closely monitor their patients responses to therapy.

Published on : Jun 23, 2023 | Views : 694 | Downloads : 2

Shareable Url :

Embed Code :

Comment

Transcript

Slide 1-

1 Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources 1 Pharmacy Informatics Town Hall August 25, 2022
Slide 2-

As a mission-driven non-profit, HIMSS offers a unique depth and breadth of expertise in health innovation, public policy, workforce development, research and analytics to advise global leaders, stakeholders and influencers on best practices in health information and technology. 2 HIMSS is a global advisor and thought leader supporting the transformation of the health ecosystem through information and technology. With more than 350 employees, HIMSS has operations in: North America | Asia Pacific | Europe | Latin America | Middle East | United Kingdom
Slide 3-

About NCPDP Founded in 1977, NCPDP is a not-for-profit, ANSI-accredited, Standards Development Organization with over 1,500 members representing virtually every sector of the pharmacy services industry. NCPDP members have created standards such as the Telecommunication Standard and Batch Standard, the SCRIPT Standard for e-Prescribing, the Manufacturers Rebate Standard and more to improve communication within the pharmacy industry. Our data products include dataQ®, a robust database of information on more than 80,000 pharmacies, HCIdea®, a database of continually updated information on more than 2.5 million prescribers, and resQ™, an industry pharmacy credentialing resource. NCPDP's RxReconn® is a legislative tracking product for real-time monitoring of pharmacy-related state and national legislative and regulatory activity. www.ncpdp.org 3
Slide 4-

4 Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources Senior Clinical Analyst Office of Therapeutic Biologics and Biosimilars (OTBB) U.S. Food and Drug Administration (FDA) Nina Brahme has worked with the Office of Therapeutic Biologics and Biosimilars (OTBB) at the U.S. Food and Drug Administration for over three years as part of an interdisciplinary team which supports communicating clear, consistent scientific advice for biosimilar and interchangeable product development. Previously, Nina was a product quality reviewer in FDA’s Office of Biotechnology Products (OBP). Nina received her Bachelors degree in Molecular and Cell Biology from University of California Berkeley and her PhD in Cell Biology from Yale University. As a National Cancer Institute Postdoctoral Fellow, she completed a Masters of Public Health from Harvard T.H. Chan School of Public Health. Nina Brahme, Ph.D., M.P.H.
Slide 5-

5 Project Coordinator Office of Therapeutic Biologics and Biosimilars (OTBB) U.S. Food and Drug Administration (FDA) Shelley Skibinski is a Project Coordinator at the U.S. Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars (OTBB). As a member of OTBB’s Policy Staff, Shelley works on policy and regulatory issues that impact biosimilar and interchangeable product development. She is also the lead for large-scale projects such as the Purple Book Database of Licensed Biological Products. Shelley graduated as a Doctor of Pharmacy from the Bernard J. Dunn School of Pharmacy at Shenandoah University. She joined FDA in January 2021 in her current role. Shelley Skibinski, Pharm.D. Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources
Slide 6-

6 Senior Communication Advisor Office of Therapeutic Biologics and Biosimilars (OTBB) U.S. Food and Drug Administration (FDA) Sarah Ikenberry is a Senior Communication Advisor at the Office of Therapeutic Biologics and Biosimilars (OTBB) in the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). She provides communication advice and support to senior leaders and the agency about communicating strategic priorities, initiatives, and educational information about biosimilar and interchangeable products. Sarah received her Master of Arts in Communication from Johns Hopkins University. Sarah Ikenberry, M.A. Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources
Slide 7-

Disclosures Nina Brahme, Shelley Skibinski and Sarah Ikenberry have no relevant financial relationships to disclose. 7
Slide 8-

Nina Brahme, Ph.D., M.P.H. 8 Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources
Slide 9-

9 Learning Objectives Pharmacist – 1. Describe how biologics differ from small molecules (size, complexity, manufacturing) and explain why some biologics cannot be copied exactly. 2. Compare and contrast the development, statutory requirements, and approval process for new biologics and for biosimilars/interchangeables. 3. Compare and contrast the requirements for generics and biosimilars/interchangeables. 4. Describe the U.S. Food and Drug Administration's (FDA) educational resources available for healthcare providers to learn more about biosimilar and interchangeable products. 5. Explain how to use the Purple Book Database of Licensed Biological Products. At the end of this presentation, learners will be able to: 9
Slide 10-

10 Learning Objectives continued Pharmacy Technician - 1. Describe how biologics differ from small molecules (size, complexity, manufacturing) and explain why some biologics cannot be copied exactly. 2. State the development, statutory requirements, and approval process for new biologics and for biosimilars/interchangeables. 3. State the requirements for generics and biosimilars/interchangeables. 4. Describe the U.S. Food and Drug Administration's (FDA) educational resources available for healthcare providers to learn more about biosimilar and interchangeable products. 5. Explain how to use the Purple Book Database of Licensed Biological Products At the end of this presentation, learners will be able to: 10
Slide 11-

Biosimilars : Original Biologic Products Generics : Original Drug Products What are Biosimilars? 11
Slide 12-

What are Generics? A molecule A molecule A pill A pill     Approved as New Drug Applications (NDA’s) Approved as Abbreviated New Drug Applications (ANDA’s) 12
Slide 13-

Biological Products Biologics are generally large and produced from living systems such as a microorganisms (yeast or bacteria), or plant or animal cells They range in size and complexity Examples: therapeutic proteins (hormones, growth factors, monoclonal antibodies), vaccines, blood products Modified from Mellstedt H, EJC Supplements II, 2013, 3, I - II 13
Slide 14-

Protein frame is an exact copy Add-ons and other post-translational changes create “variants” Therapeutic Proteins: Complexity A consistent mix of variants exists in every sample/dose 14 Biosimilars Info Sheet Level 1: foundational concepts
Slide 15-

15 Q: Why use the term “biosimilar” instead of “generic?” A: Because, unlike chemical drugs, biologics can’t be copied exactly Q: Why can’t a biologic be copied exactly? A: Because biologics aren’t made up of identical versions of the same molecule. They are a mix of versions of a molecule.
Slide 16-

How does FDA determine biosimilars to be acceptable for approval? 16
Slide 17-

Biological Product Regulation 351(a) “stand alone” Biologics License Application (BLA): contains all information and data necessary to demonstrate that the proposed biological product is safe, pure and potent The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) Created an abbreviated licensure pathway [351(k)] for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference product (originator 351(a)-licensed biological product) 17
Slide 18-

Key Definitions from the BPCI Act 18 Interchangeable Product A reference product is the single biological product, already approved by FDA, against which a proposed biosimilar product is compared A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product Biosimilar Product Biosimilar Product Reference Product Interchangeable Product -Is a biosimilar -Expected to produce the same clinical result as the reference product (RP) in any given patient -Switching between the proposed product and the RP does not ↑safety risks or ↓effectiveness compared to using the RP without switching Reference Product 18
Slide 19-

Different Goals for “Stand-alone” vs. Biosimilar Development “Stand-alone”: 351(a) BLA Goal: To establish de novo safety and efficacy of a new product “Abbreviated”: 351(k) BLA Goal: To demonstrate biosimilarity (or interchangeability) to a reference product based on comparative assessments 19
Slide 20-

Comparative Analytical Assessment is the Foundation Compare multiple physicochemical and biological attributes of each product Analytical studies are generally more sensitive than clinical studies in detecting differences between products, should differences exist A biosimilar product with highly similar structure and function to the reference product should behave like the reference product Analyze multiple lots of the reference product and proposed biosimilar for product quality attributes, including: Primary amino acid sequence Higher order structure (protein folding) Post-translational modifications (glycosylation, etc.) Heterogeneity (charge, size, aggregates, etc.) Biological activity - evaluation of attributes that affect the known MoAs 20
Slide 21-

Case Study of Interchangeable Biosimilar Semglee (insulin glargine-yfgn or MYL-1501D) 21
Slide 22-

Semglee (insulin glargine-yfgn) vs US-Lantus: Quality Attributes Compared* *Not an exhaustive list; Information summarized and adapted from the Product Quality Review available on drugs@fda 22
Slide 23-

Green lines represent the QR limits (mean ± 3SD of US-Lantus). Additional MYL-1501D lots were analyzed for this assay and as part of the overall CAA Case study MYL-1501D vs. US-Lantus Protein Concentration Example Adapted from the Product Quality Review available on drugs@fda These studies provide data to support the structural and functional similarity of MYL-1501D to US-Lantus and evaluate the impact of any differences identified. Protein Concentration IU/mL 23
Slide 24-

Role of Clinical Studies 24 As a scientific matter, FDA expects an adequate clinical PK, and PD if relevant, comparison between the proposed biosimilar product and reference product and a clinical immunogenicity assessment Additional clinical studies are not considered “pivotal” in the way Phase 3 clinical trials are for standalone development Add to the totality-of-the-evidence that supports a demonstration of biosimilarity 24
Slide 25-

Type of Clinical Data Clinical Pharmacology Studies PK and/or PD is generally considered more sensitive than clinical efficacy endpoints when assessing for differences between products, should they exist. PK and PD similarity data support a demonstration of biosimilarity with the assumption that similar exposure (and pharmacodynamic response, if applicable) will provide similar efficacy and safety (i.e., an exposure-response relationship exists). Use of a single scientifically appropriate PD biomarker or a composite of more than one relevant PD biomarker to demonstrate PD similarity can reduce residual uncertainty. At least 1 clinical study that includes a comparison of the immunogenicity of the proposed and reference product generally will be expected. A comparative clinical study is considered necessary if there are residual uncertainties about whether there are clinically meaningful differences between the proposed product and reference product based on structural and functional characterization, animal testing, human PK and PD data, and clinical immunogenicity assessment. 25 25
Slide 26-

Semglee (insulin glargine-yfgn) vs US-Lantus: PK/PD Compared Adapted from the Multi-Discipline Review available on drugs@FDA PK/PD Similarity Study Euglycemic clamp study in healthy subjects Similar Exposure Similar Efficacy Similar Safety 26
Slide 27-

Case Study – Summary for Biosimilarity Comparative analytical data demonstrate that MYL-1501D and US-Lantus are highly similar, notwithstanding minor differences in clinically inactive components PK/PD similarity data in healthy subjects support the demonstration of no clinically meaningful differences in safety, purity, and potency The totality of the data support the Applicant’s claim that MYL-1501D is biosimilar to US-Lantus FDA Review Analytical studies A clinical study or studies Animal studies Totality of the evidence 27
Slide 28-

Key Takeaways: Biosimilarity Biological products are generally large molecules that range in size and complexity. Small variations in biologics, whether they are reference products, biosimilars or interchangeable biosimilars, can be expected within each lot (dose) or between lots (doses). The manufacturing process for biologics is carefully controlled and monitored to keep the variations within acceptable limits. Comparative analytical data are the foundation of a biosimilarity assessment; a biosimilar is shown to be highly similar by extensive analytical comparisons of structure and function. A biosimilar manufacturer must also demonstrate that the product has no clinically meaningful differences from the reference product. This may be demonstrated through human pharmacokinetic (i.e., exposure) and pharmacodynamic (i.e., response) studies, an assessment of clinical immunogenicity, and, if needed, a comparative clinical study in patients. 28
Slide 29-

Why Seek Interchangeability? An interchangeable biosimilar product can be substituted for the reference product at pharmacies without the intervention of the prescribing health care provider, subject to state pharmacy laws. Pharmacy Substitution 29 Interchangeable Biological Products
Slide 30-

Interchangeable Product Examples: Cyltezo *Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry | FDA The extent of additional data, including clinical data needed to support a demonstration of interchangeability will depend on factors, such as the product’s complexity or a product’s specific immunogenicity risk. Cyltezo (adalimumab-adbm) Cyltezo previously approved as biosimilar to US-Humira Switching study designed as recommend in guidance* 30
Slide 31-

*Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products | FDA Semglee (insulin glargine-yfgn) Comparative analytical assessment to support “highly similar” conclusion Clinical pharmacology PK/PD similarity study Immunogenicity assessment justification submitted, per guidance* Switching study was determined to be unnecessary Relatively small, structurally uncomplicated, well characterized Minimal or no risk of clinical impact from immunogenicity Interchangeable Product Examples: Semglee 31
Slide 32-

Key Takeaways: Interchangeability Interchangeable biosimilar products are pharmacy substitutable without intervention of the prescribing health care provider, subject to state laws. FDA’s approval of an interchangeable biological product does not indicate a higher standard of biosimilarity. Different statutory criteria reflect scientific considerations related to the potential for substitution without the intervention of the prescriber. Patients and healthcare providers do not need to wait for a biosimilar product to “become” an interchangeable product. Business considerations may influence applicants’ decisions about which type of licensure to seek. 32
Slide 33-

33 Using Biosimilar and Interchangeable Products
Slide 34-

Patients and healthcare providers can be confident in the safety and effectiveness of a biosimilar and interchangeable product and prescribe them by name, just as for the reference product. Biosimilar and interchangeable biosimilar products can be used in patients who have previously been treated with the reference product (i.e., treatment-experienced), and in patients who have not previously been treated with the reference product (i.e., treatment-naïve). Interchangeable biosimilars may be substituted for the reference product without the intervention of the prescribing health care provider, subject to state laws. Using Reference, Biosimilar, and Interchangeable Products Reference Product 34
Slide 35-

Biosimilar and Interchangeable Labeling The labeling summarizes the scientific information health care practitioners need for safe and effective use of the product. A biosimilar or interchangeable is not required to have the same labeling as its reference product (e.g., a it can be labeled for fewer than all indications or there may be differences in storage/preparation). Health care professionals are advised to review the labeling (i.e., prescribing information) of the biosimilar or interchangeable to determine the conditions of use (e.g., indications, dosing regimens) and routes of administration for which the product is approved. FDA recommends that Highlights of Prescribing Information contain a “Biosimilarity Statement” or an “Interchangeability Statement” describing the product’s relationship to its reference product. 35
Slide 36-

Biosimilarity Statement *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NEXSYMEO as been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. NEXSYMEO (replicamab-cznm) is biosimilar* to JUNEXANT (replicamab-hjxf). 36
Slide 37-

Biological Product Naming Convention Most biological products, including more recently approved originator biologics, biosimilar, and interchangeable products, are subject to FDA’s naming policy. The naming convention for biological products is a proper name consisting of a core name and a unique 4-letter suffix. The suffix will be attached with a hyphen to the core name of each product. Core name: component shared among biological products that contain related drug substances (eg, filgrastim, epoetin alfa) Suffix: four lowercase letters that are unique and devoid of meaning(eg, -cznm, -hixf) Proper name: core name + suffix For example, for hypothetical products sharing the fictitious core name replicamab, the proper names would include a unique suffix: Originator biological product: replicamab-cznm Related biological product: replicamab-rzbh Biosimilar product: replicamab-hixf Interchangeable biosimilar product: replicamab-tkpl 37
Slide 38-

03/06/15 Zarxio (filgrastim-sndz) 04/05/16 Inflectra (Infliximab-dyyb) 08/30/16 Erelzi (etanercept-szzs) 09/23/16 Amjevita (adalimumab-atto) 04/21/17 Renflexis (Infliximab-abda) 08/25/17 Cyltezo (adalimumab-adbm) 09/14/17 Mvasi (bevacizumab-awwb) 12/01/17 Ogivri (trastuzumab-dkst) 12/13/17 Ixifi (infliximab-qbtx) 05/15/18 Retacrit (epoetin alfa-epbx) 06/04/18 Fulphila (pegfilgrastim-jmdb) 07/20/18 Nivestym (filgrastim-aafi) 10/30/18 Hyrimoz (adalimumab-adaz) 11/02/18 Udenyca (pegfilgrastim-cbqv) 11/28/18 Truxima (rituximab-abbs) 12/14/18 Herzuma (trastuzumab-pkrb) 01/18/19 Ontruzant (trastuzumab-dttb) 03/11/19 Trazimera (trastuzumab-qyyp) 04/25/19 Eticovo (etanercept-ykro) 06/13/19 Kanjinti (trastuzumab-anns) 06/27/19 Zirabev (bevacizumab-bvzr) 07/23/19 Ruxience (rituximab-pvvr) 07/23/19 Hadlima (adalimumab-bwwd) 11/04/19 Ziextenzo (pegfilgrastim-bmez) 11/15/19 Abrilada (adalimumab-afzb) 12/6/19 Avsola (infliximab-axxq) 06/10/20 Nyvepria (pegfilgrastim-apgf) 07/06/20 Hulio (adalimumab-fkjp) 12/17/20 Riabni (rituximab-arrx) 7/28/21 Semglee (insulin glargine-yfgn) 37 Approved >20 Currently marketed Timeline of Biosimilar and Interchangeable Biosimilar Approvals 09/17/21 Byooviz (ranibizumab-nuna) https://www.fda.gov/drugs/biosimilars/biosimilar-product-information 10/15/21 Cyltezo (adalimumab-adbm) Biosimilars Interchangeable Biosimilars 12/17/2021 Yusimry (adalimumab-aqvh) Rezvoglar (insulin glargine-aglr) 02/2022 Relueko (filgrastim-ayow) 04/2022 Alymsys (bevacizumab-maly) 05/26/2022 Fylnetra (pegfilgrastim-pbbk) 38 08/2/2022 Cimerli (ranibizumab-eqrn)
Slide 39-

39 Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources Shelley Skibinski, Pharm.D.
Slide 40-

40 FDA Resources and Education Materials
Slide 41-

The Purple Book Database The Purple Book Database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products. The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER). The database can be found at PurpleBookSearch.fda.gov 41
Slide 42-

The database provides patients, payors, clinicians, and others with an accessible, easy-to-use online search engine with more information about FDA-approved biological products, including biosimilar and interchangeable biological products, and their reference products. Purple Book's Features Features tailored to different user needs, including: Simple Search and Advanced Search User Guide with detailed instructions for site location functions Auto-populated search results Additional advanced search filters Data download and export options Product label links Show/hide sortable data column options Searchable glossary of terms 42 https://purplebooksearch.fda.gov
Slide 43-

Homepage & Simple Search 43 https://purplebooksearch.fda.gov
Slide 44-

Simple Search Results 44 https://purplebooksearch.fda.gov
Slide 45-

Product Details 45 https://purplebooksearch.fda.gov
Slide 46-

Advanced Search 46 https://purplebooksearch.fda.gov
Slide 47-

Interchangeable Products 47 https://purplebooksearch.fda.gov
Slide 48-

Interchangeable Products, Continued 48 https://purplebooksearch.fda.gov
Slide 49-

Glossary of Terms 49 https://purplebooksearch.fda.gov
Slide 50-

Sarah Ikenberry, M.A. 50 Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources
Slide 51-

Biosimilar Education and Outreach FDA is committed to developing effective communications to improve understanding of biosimilars among patients, healthcare providers and payors Engaging with healthcare professional and patient stakeholders Developing educational materials for healthcare prescribers, pharmacists, and patients Education is an undertaking that requires multi-stakeholder engagement FDA is committed to fulfilling their important role as one of many stakeholders 51
Slide 52-

Healthcare Provider Materials 52 https://www.fda.gov/drugs/biosimilars/health-care-provider-materials
Slide 53-

Web Content and Infographic: Uses patient-friendly language and imagery Addresses topics, concerns, and misconceptions shown to be most important to patients Tested with patients treated with a biologic & patient advocacy organizations 53 https://www.fda.gov/drugs/biosimilars/patient-materials
Slide 54-

FDA Biosimilar Materials in Spanish 54
Slide 55-

Curriculum for Healthcare Professional Programs The Biosimilar Curriculum Toolkit contains multiple types of materials to help faculty integrate biosimilars and interchangeable products into the education and professional training of healthcare students. Goal is to increase knowledge and real-world application of concepts among students in healthcare degree programs (Medicine, Nursing, Physician Asst./Assoc., and Pharmacy). Materials are designed to meet a variety of needs and are divided into two (2) levels of content. https://www.fda.gov/drugs/biosimilars/curriculum-materials-health-care-degree-programs-biosimilars 55
Slide 56-

Curriculum for Healthcare Professional Programs, continued Materials include a teaching guide, slide decks, videos, information sheets, case studies, discussion questions, exercises, and more. Topics covered include: Biologics, Biosimilars and Interchangeability Approval pathways for biological products Manufacturing and variation in biological products Labeling and prescribing of biosimilar and interchangeable biosimilar products https://www.fda.gov/drugs/biosimilars/curriculum-materials-health-care-degree-programs-biosimilars 56
Slide 57-

Medscape Continuing Education Series of Continuing Education (CE) Courses through Medscape about biosimilar and interchangeable products 57
Slide 58-

Materials and resources for patients: Videos Additional infographics and graphics Fact Sheets Materials and resources for healthcare providers: Videos Continuing Education course options through Medscape - NOW AVAILABLE! Updated Educational curriculum/teaching resources for HCP schools Future Education and Outreach Plans 58
Slide 59-

Resources Visit: www.fda.gov/biosimilars for access to all the education materials and information about biosimilar and interchangeable products. https://purplebooksearch.fda.gov/ The Purple Book: Database of Licensed Biological Products for information on biological products, including if products are biosimilar to a reference product. www.fda.gov/drugsatfda (Drugs@FDA) for information on all FDA approved drug products, including labeling and review information. Visit https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education (CDERLearn) for training and education opportunities 59
Slide 60-

Available Educational Materials on FDA Webpages Quality Clinical Trial Evidence Extrapolation Interchangeability Switching/Substitution Biosimilar Development, Review, and Approval | FDA Prescribing Biosimilar and Interchangeable Products | FDA Interchangeable Biological Products Drugs@FDA: FDA-Approved Drugs Webinars for CE Product Information Biosimilar and Interchangeable Biological Products: An Updated Review of Scientific Concepts and Practical Resources | FDA The Purple Book: Database of Licensed Biological Products Biosimilar Regulatory Review and Approval Patient Materials | FDA 60
Slide 61-

CPE INSTRUCTIONS (LIVE VERSION):Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources Pharmacist Code: ddusVV Technician Code: 789F9F The deadline for obtaining your CPE Credit is 9/24/2022. The deadline is non-negotiable due to CPE Monitor reporting policies. Redeem your credit online at CEimpact.com *If this is the first time you have utilized the CEimpact Learning Management System (LMS) you will need to create an account. From the CEimpact.com Homepage – enter the code provided in the ‘Enter Code’ box and click SUBMIT. Complete the Exam & Evaluation as prompted; click SUBMIT to send your information to CPE Monitor. Follow instructions to access your CPE Statement of Credit on CPE Monitor. 1 1 2 3 61
Slide 62-

CPE INSTRUCTIONS (On-Demand Version):Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources Pharmacist Code: vm5Wfm Technician Code: eeaHvi The deadline for obtaining your CPE Credit is 8/25/2025. The deadline is non-negotiable due to CPE Monitor reporting policies. Redeem your credit online at CEimpact.com *If this is the first time you have utilized the CEimpact Learning Management System (LMS) you will need to create an account. From the CEimpact.com Homepage – enter the code provided in the ‘Enter Code’ box and click SUBMIT. Complete the Exam & Evaluation as prompted; click SUBMIT to send your information to CPE Monitor. Follow instructions to access your CPE Statement of Credit on CPE Monitor. 1 1 2 3 Click on My Courses. Then click on the Course Title in your Enrolled folder. Read the course instructions.
Slide 63-

63 Questions?
Slide 64-

Thank you from www.fda.gov/biosimilarsEmail Questions or Comments to: CDER-BiologicsBiosimilarsInquiries@fda.hhs.gov or DRUGINFO@fda.hhs.gov Thank You 64
Slide 65-

Save the Date!Future HIMSS/NCPDP Townhall Sessions September 27 @ 12:00pm ET – Topic: Pharmacy Standards for Value-based Arrangements 65
Slide 66-

UPCOMING NCPDP WEBINARS: NCPDP Pharmacy Standards – HIPAA Updates, Sept. 15 at 12 PM ET Expanding Into Home-Based Services to Increase Revenue, Sept. 21 at 1PM ET https://www.ncpdp.org/Webinars.aspx 66
Slide 67-

NCPDP’s 2022 Virtual Educational Summit Telecommunication F6 & Related Standards: Prepare for Implementation November 15-16, 2022 SAVE THE DATE! 67
Slide 68-

Call for Proposals for #NCPDP23,“The Great Race to Close Gaps in Care” is Now Open!View suggested topics and submit a proposal today: https://ncpdp.org/AC/call-for-proposals-info.aspx 68
Slide 69-

SAVE THE DATE! 69 HIMSS23 Global Conference April 17-21, 2023 | Chicago, IL Call for Reviews is now open through August 29, 2022 https://www.himss.org/global-conference/call-reviewers Call for Proposals is now open through September 12, 2022 https://www.himss.org/global-conference/call-proposals Registration opens fall 2022
Slide 70-

Thank you.Contact Gwynne Jelbaouigwynne.jelbaoui@himss.org 312-638-9490 70