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  1. Biosimilars WhatareBiosimilars DifferencetoGenerics Whatcanthey do forus in thefuture 09.09.2016 IHS

  2. Biosimilars • Biological Products • Manyoftoday’simportantmedicationsarebiologicalproducts. Biological productsaremadefromlivingorganisms. • The material theyaremadefromcancomefrommanysources, includinghumans, animalsandmicroorganisms such asbacteriaoryeast. Biological productsaremanufacturedthroughbiotechnology, derivedfromnaturalsourcesor, in somecases, producedsynthetically. • Biological productsareamongthemedicationsusedtotreatconditions such as rheumatoid arthritis, anemia, lowwhitebloodcellcounts, inflammatoryboweldisease, skinconditions such aspsoriasisandvariousformsofcancer.  • 09.09.2016 IHS

  3. Biosimilars • Biological Products • Most biologicalproductsaremorecomplex in structureandhavelarger moleculesormixturesofmolecules(however can consist of relatively small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies) thanconventionaldrugs (e.g. Aspirin, also calledsmallmoleculedrugs). • Conventionaldrugsaremadeof pure chemicalsubstancesandtheirstructurescanbeidentified. • Most biologics, however, arecomplexmixturesthataremoredifficulttoidentifyorcharacterizeandtomanufacture. • 09.09.2016 IHS

  4. BiosimilarsProductionfacilitiesforBiologics / Biosimilars • 09.09.2016 IHS

  5. Biosimilars • Whatarebiosimilarandinterchangeablebiologicalproducts? • Therearetwonewtypesofbiologicalproducts: biosimilarandinterchangeable. Biosimilarsare a type ofbiologicalproductthatarelicensed (approved) by FDA oranotherhealthauthority (HA, e.g. EMA) becausetheyarehighlysimilarto an already FDA oranother HA approvedbiologicalproduct, knownasthe • biologicalreferenceproduct(referenceproduct), andhavebeenshowntohavenoclinicallymeaningfuldifferencesfromthereferenceproduct. • An interchangeablebiologicalproduct, in additiontomeetingthebiosimilaritystandard, isexpectedtoproducethe same clinicalresultasthereferenceproduct in anygivenpatient. • 09.09.2016 IHS

  6. Biosimilars • Will biosimilarswork in the same wayasthebiologicalreferenceproducttheywerecomparedto? • Yes, biosimilarshavenoclinicallymeaningfuldifferences in termsofsafetyandeffectivenessfromthereferenceproducttheywerecomparedto.  In addition, a biosimilarneedstohavethe same mechanismofactionasthereferenceproductit was comparedto, whichmeansit will work in the same wayasthereferenceproduct. • The FDA oranother HA will onlyapprove a biosimilarproductifithasthesamemechanismofaction, route ofadministration, dosage form, andstrengthasthereferenceproduct. Additionally, a biosimilarcanonlybeapprovedfortheindicationsandconditionsofusethathavebeenpreviouslyapprovedforthereferenceproduct. • 09.09.2016 IHS

  7. Biosimilars • Are biosimilarsgenericversionsofbiologicalproducts? • No, genericdrugsarecopiesof brand-name drugs, havethe same activeingredient, andarethe same asthosebrandnamedrugsin dosage form, safety, strength, route ofadministration, quality, performancecharacteristicsandintendeduse. Thatmeansthebrand-name andthegenericarebioequivalent. • Biosimilarsarehighlysimilartothereferenceproducttheywerecomparedto, but haveallowabledifferencesbecausetheyaremadefromlivingorganisms. • Biosimilars also havenoclinicallymeaningfuldifferences in termsofsafety, purity, andpotencyfromthereferenceproduct. • 09.09.2016 IHS

  8. Biosimilars • What are Generic Drugs? • A generic drug is identical--or bioequivalent--to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.  Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. Generic drugs save consumers, hospitals and health insurance systems quite a lotofmoney. • 09.09.2016 IHS

  9. Biosimilars • WHY can they be cheaper? • New drugs, like other new products, are developed under patent protection.  The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect.  When patents or other periods of exclusivity expire, manufacturers can apply to the FDA or another HA to sell generic versions.  The process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.  This applies to drugs first marketed after 1962 (US market). • 09.09.2016 IHS

  10. Biosimilars • ExamplesforBiosimilars • Approvedby FDA: • InflectraisbiosimilartoRemicade (infliximab). • It’sapprovedfor multiple conditions, including: • Crohn’sdisease • Ulcerativecolitis • Rheumatoid arthritis • Ankylosingspondylitis • Psoriaticarthritis • Plaque psoriasis • 09.09.2016 IHS

  11. Biosimilars • ExamplesforBiosimilars • Zarxio (filgastrim-sndz) isbiosimilartoNeupogen • It‘sapprovedfor multiple conditions, including: • Cancer • HematopoieticStemCell Transplantation • Neutropenia • ErelziisbiosimilartoEnbrel (Etanercept) • It‘sapprovedfor multiple conditions, including: • Autoimmune diseases such as rheumatoid arthritis, plaquepsoriasis, • psoriaticarthritis, juvenile idiopathicarthritis (JIA), ankylosingspondylitis(AS) • 09.09.2016 IHS

  12. Biosimilars • Biologics versus Biosimilars • Biologics are different from conventional medications. Conventional medications—drugs—are generally made from chemicals or chemically synthesized, and therefore their structure can be relatively easily defined. Unlike conventional medications, biologics can’t be made by following a chemical “recipe.” • Biologics come from living organisms that are variable in nature. Because of that, developing biologics is a far more complex process than manufacturing drugs. • Currently, biologics are among the fastest growing segments of the prescription product market. • Pharmaceutical Players have a great interest to enter this market with biosimilars, but • 09.09.2016 IHS

  13. Biosimilars but…………… Obstructive role of state and bureaucracy and time involved in testing and licensing slow down new entrants to the market New entrants face additional commercial risk that they may be instantly undercut and even driven out of business by the incumbent slashing its own prices Private sector pharmaceutical companies with shareholders have a right and a responsibility to turn a profit Politicians and society at large object to profiteering of pharmaceutical companies and put public pressure when there are obvious excesses in pricing Some pharmaceutical companies decide not to take the risk under given circumstances 09.09.2016 IHS

  14. Biosimilars Increased Options, Lower Costs? Biosimilars are likely to create greater competition in the medical marketplace. This could not only increase treatment options for patients but also lead to less expensive alternatives to comparable products. With an increasing number of biosimilars on the market, consumers may expect to get equally safe and effective treatment, but at lower costs. 09.09.2016 IHS

  15. Biosimilars Thankyouforyourattention! Questions? 09.09.2016 IHS