Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017
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This document provides information about an upcoming webinar on drug types including biosimilars and generics. It outlines details like the speaker, how to ask questions during the webinar, and instructions for accessing the webinar archive and following along on Twitter. It also provides brief bios of the speaker and gives technical instructions for participating in the webinar platform. Finally, it lists some resources and includes a standard disclaimer.
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Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017
- 1. Drug Types: Biosimilars, Generics, and More
- 2. TODAY’S WEBINAR SPEAKER(S) Stevan Lalich, Pharm.D. QUESTIONS Ask a question in the panel on the RIGHT SIDE of your screen WEBINAR ARCHIVE FightCRC.org/webinar TWEET ALONG Follow along via Twitter – use the hashtag #CRCWebinar POST WEBINAR Expect an email with links to the material & a survey. If you fill it out, we’ll send you a Fight CRC bracelet.
- 3. We are using LogMeIn GoToWebinar platform The side control panel can be adjusted using the orange arrow Questions are asked by opening the “Questions” tab – the arrow opens the box Not all questions are addressed during the presentation depending on time and quantity, but if necessary will be followed up individually If you are new to GoToWebinar and experience streaming problems, shut down other high bandwidth services such as Facebook, IM, or hangout systems during presentation The “Audio” tab allows you to select either your computer or phone to listen in WEBINAR TECH
- 4. RESOURCES TABOO-TY PODCAST MINI MAGAZINES YOUR GUIDE IN THE FIGHT
- 5. FIGHTCOLORECTALCANCER DISCLAIMER The information and services provided by Fight Colorectal Cancer are for general informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnoses or treatment. If you are ill, or suspect that you are ill, see a doctor immediately. In an emergency, call 911 or go to the nearest emergency room. Fight Colorectal Cancer never recommends or endorses any specific physicians, products or treatments for any condition.
- 6. StevanLalich Pharm.D. 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.
- 7. Review of Biosimilars Stevan Lalich, PharmD CVS Health December 12, 2017
- 8. • 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 44108
- 9. 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 PROCESS Predictable 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. 44108
- 10. “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
- 11. 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……)
- 12. Example of clinically insignificant differences
- 13. 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 44108
- 14. 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.
- 15. 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 44108
- 16. 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.
- 17. 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.
- 18. FDA-Approved Biosimilar Products FDA approval does not necessarily mean commercially available due to existing drug patents still in place.
- 19. 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
- 20. FDA Information on Biosimilars • https://www.fda.gov/drugs/developmentapprovalprocess/howdrugs aredevelopedandapproved/approvalapplications/therapeuticbiologic applications/biosimilars/
- 21. Drug Label Information Overview
- 22. 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
- 38. 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
- 39. How to Read a Prescription Label
- 41. Questions about Prescription Drug Therapy
- 42. 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
- 43. Q & A SNAP A #STRONGARMSELFIE Bayer HealthCare will donate $1 for every photo posted (up to $25,000). Flex a “strong arm” & post it to Twitter or Instagram using the hashtag #StrongArmSelfie
- 44. CONTACT US CALL TOLL FREE 1.877.427.2111 FightCRC.org
Editor's Notes
- Biopharmaceuticals are made by harvesting proteins that are produced and secreted by specially genetically engineered living cells (proteins). The production process is far more complex. The quality of the end product (including therapeutic efficacy and safety) may depend on the manufacturing process. What are biologic medicines? A biologic medicine is a large molecule typically derived from living cells and used in the treatment, diagnosis or prevention of disease. Biologic medicines include therapeutic proteins, DNA vaccines, monoclonal antibodies and fusion proteins. Biologic medicines are often 200 to 1,000 times the size of a small molecule drug and are far more complex structurally. They are also highly sensitive to their manufacturing and handling conditions, making them more difficult to characterize and produce than small molecule drugs. Due to both their size and sensitivity, biologic medicines are almost always injected into a patient’s body and individual patient responses can depend on how a biologic is made. http://www.amgen.com/pdfs/misc/Biologics_and_Biosimilars_Overview.pdf Today’s biologic medicines have made a significant difference to the lives of patients with serious illnesses, including cancer, blood conditions, auto-immune disorders such as rheumatoid arthritis (RA) and psoriasis, and neurological disorders like multiple sclerosis. Recreating human proteins into biologic medicines has revolutionized how we treat disease. Examples of non specialty biologics: FluMist® and Gardasil®
- Aspirin versus Humira The inherently complex nature of biologics makes them expensive to develop and impossible to copy in the manner traditionally associated with the approval of generic drugs. Most biologics are produced in living organisms, such as plant or animal cells, whereas small molecule drugs (most pharmaceuticals) are typically manufactured through chemical synthesis. Thus, even creating "similar" biologics is an inherently unpredictable process. Highlighting these differences is key to showing why we cannot use the traditional generic approval and interchange process created by the Hatch-Waxman act.
- Key Message to convey- Each pathway has different objective, thus they’re constructed differently- Reference biologic application- must demonstrate the new drug/biologic is safe and effective based primarily on clinical trials. Biosimilar application- must demonstrate high similarity between the proposed biosimilar and a reference product, so that it can rely on comparative data of the reference drug. The goal is not to independently establish safety and effectiveness of the proposed biosimilar. Analytical studies- where Physicochemical characterization occurs; the foundation for showing biosimilarity. The more comprehensive/robust the data, the stronger the justification for selective and targeted approach to animal and human testing. Examples of analytical studies- Primary amino acid sequence, molecule structure, post translational modifications, lot to lot variability Non-Clinical studies- where biological characterization occurs using functional assays to exactly understand the drug’s mechanism of action in order to predict the clinical relevance of any observed difference in structure. Examples of function assays- bioassays, binding assays, enzyme kinetics Clinical Pharmacology studies- Animal Pharmacokinetic and pharmacodynamic studies and toxicity and immunogencity studies conducted depending on results from previous two steps. Useful if safety uncertainties remain before first-in-man studies. Clinical studies- Scope and magnitude for clinical studies depends on extent of residual uncertainly from previous steps. No need to independently establish safety and efficacy. Human PK/PD and immunogenicity studies required and are sufficient to demonstrate safety, purity, potency in one or more appropriate conditions of use for which the reference product is licensed. The FDA will make its determination regarding the approval on the basis of the ‘totality of the evidence’ (evidence provided from steps listed here) and each application will be evaluated on a case by case basis. Manufacturing sites and any manufacturing changes are closely reviewed by the FDA for clinical relevance Batch-to-batch variability occurs for reference products, and variability for biosimilars is maintained within this accepted range. ny change in manufacturing process applicant must notify the FDA of a change to an approved application and before distributing a drug product made with such changes
- Objective: regulatory environment/education slides for biosimilars The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. An interchangeable biological product is biosimilar to an FDA-approved reference product and meets additional standards for interchangeability. An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product. Biosimilarity does not imply interchangeability FDA requires licensed biosimilar and interchangeable biological products to meet the Agency’s rigorous standards of safety and efficacy. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product. Additional info: What are biosimilars? http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm436399.htm Biosimilars are often referred to as follow-on biologics, generic biologics or follow-on proteins Biosimilars are new versions of existing trade-name biological products whose patents have expired While “highly similar” biosimilars are not “identical” to the reference product They do not utilize the same living cell line, production process, or raw material as the innovator drug Biosimilars are not generics.