Generic Drugs                                       3rd Year lecture in the “Biotechnology in                             ...
Michael McNamara    Biography       Over 25 years senior management experience in multinational        agriculture, biote...
Generic Drugs – Key Questions    Questions you should be able to answer at the end of this lecture       What is a generi...
Summary of Approach       What is a generic?         –   Simple generics         –   Complex generics, super generics gen...
What is a Generic? – Simple Generic       a drug product that is comparable to brand/reference listed drug product in    ...
What is a Generic? – Simple Generic       Compared with the innovator the generic drug has         – Same API (active pha...
What is a Generic? – Simple Generic    Regulatory Submission      Innovator                          Generic      Labellin...
Generic Drugs – Simple Generic    National Regulatory Authority (eg FDA, TGA, MHRA etc)         Brand   Generic    monitor...
Generic Drugs – Comment on Quality    • Quality of generic drugs compared with innovator often controversial (in    public...
Complex Generic Drugs        Incomplete phyisco-chemcial comparability eg          –   Different Dosage form          –  ...
Example of Simple Generic Drug     -Ondansetron                                                           C18H19N3O       ...
Example of Biosimilar      -Erythropoietin (EPO)     •Glycoprotein, 165 aa, aprox. 30 kDa, single S-S bond     •Peptide co...
Biosimilars – US Europe     Comparison          Note 4: USA Draft Guidelines issued in 201113        USA Updated/Final gui...
Biosimilars – Comparison with      Simple Generic Drugs     • Biosimilars are comparable to, not substitutable for innovat...
Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]...
Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]...
Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]...
Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]...
Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]...
Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]...
Generics – IP Strategies       1. Wait for expiry of all relevant patents and data exclusivities       2.At expiry of data...
Innovator IP Strategies      1.Evergreening – in addition to patent on API          • Patents for salts, hydrates and enan...
Position of Generics in Health Care       •Innovator Companies charge higher prices for drugs during period of       paten...
Position of Generics in Health Care       •Generics make Affordable Medicines available to public           • Generic drug...
Generic Drugs                                        3rd Year lecture in the “Biotechnology in                            ...
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Generic Drugs Michael Mc Namara May 12

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Lecture to Biotechnology in Practice Course University of Melbourne

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Generic Drugs Michael Mc Namara May 12

  1. 1. Generic Drugs 3rd Year lecture in the “Biotechnology in Practice” course, University of Melbourne May 2012 Michael McNamara MSc MRACI C Chem Pharma & Biotech Innovation ph 03 94997193 mobile 04077137681 michael.mcnamara@live.com.au PBI
  2. 2. Michael McNamara Biography  Over 25 years senior management experience in multinational agriculture, biotechnology and pharmaceutical companies  Specialist in innovation in the biotech and pharmaceutical sectors with a focus on the development of human therapeutics  Research interests include drug delivery involving conventional and nanotechnology approaches  Senior management positions in CSL, Fauldings, Mayne Pharma and Hospira including R&D Director at Mayne and Hospira.  Experience with simple & complex generics including non- infringement of patents and biosimilars  Consultancy in biotech and pharmaceutical areas established in2 2009 Pharma & Biotech Innovation
  3. 3. Generic Drugs – Key Questions Questions you should be able to answer at the end of this lecture  What is a generic?  How might biotechnology be involved in generics?  Why do generics businesses exist?  How do generics businesses survive?  How do generics businesses manage intellectual property issues and in what way(s) is this different to a non-generic bio / pharma company?  What might happen to the quality of healthcare if there were no generics3 companies?
  4. 4. Summary of Approach  What is a generic? – Simple generics – Complex generics, super generics generics – Biosimilars  Commercial Aspects – Market Size and Opportunity – Product lifecycle and generics businesses – Cost pressures and globalisation in the generics business  Intellectual Property – IP Protection for Drugs – The innovator strategies – The generic strategies  Position of Generics in Health Care4
  5. 5. What is a Generic? – Simple Generic  a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use” *  Brand/reference (usually innovator) listed drug product is a product – which has full safety and efficacy information submitted to FDA, TGA etc – Product (usually the innovator) registered and already marketed in country of interest.  Studies to demonstrate comparability with innovator product include – Laboratory studies  Chemical content and purity  Dissolution studies for oral products  Microbiological safety  Stability – Clinical Bioequivalence  Not needed for some products eg simple intravenous solutions5 * "Generic Drugs", Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  6. 6. What is a Generic? – Simple Generic  Compared with the innovator the generic drug has – Same API (active pharmaceutical ingredient)  Different salt forms, hydrates and crystal forms of API generally OK – Same route of administration  Eg oral, intravenous, subcutaneous not equivalent – Same dosage form  Oral -Tablet or capsule not interchangeable  Pareneteral - solution and freeze dried not interchangeable – Same strength eg 40mg tablet; 10mg/mL injection – Same conditions of use eg administer with food etc – Inactive ingredients approved for a similar drug - Same drug blood profile as innovator ie is bioequivalent6  Generic is interchangeable with innovator in clinical use
  7. 7. What is a Generic? – Simple Generic Regulatory Submission Innovator Generic Labelling Labelling Pharm/Tox Pharm/Tox Chemistry Chemistry Manufacturing Manufacturing Controls (QC tests, validation) Controls (QC tests, validation) Microbiology Microbiology Inspection (audit of facilities) Inspection (audit of facilities) Testing Testing Animal Studies Clinical Studies Bioequivalence only Phase 1, 2, & 37 Bioavailability studies
  8. 8. Generic Drugs – Simple Generic National Regulatory Authority (eg FDA, TGA, MHRA etc) Brand Generic monitors and evaluates drug product name Bioequivalence to innovator (reference listed drug) X X Adherence to cGMP by manufacturer X X Active and inactive ingredients X X Finished drug product (chemical equivalence to innovator) X X Labelling of drug product (equivalence to innovator) X X Major changes to product/process with prior approval needed X X Adverse reactions/adverse health effects monitored/reported X X Manufacturing plants with periodic inspections and audits X X8 Monitor ongoing quality of drug (annual reports etc) X X
  9. 9. Generic Drugs – Comment on Quality • Quality of generic drugs compared with innovator often controversial (in public view) • Scientific evidence does not support concerns “The pharmaceutical quality and therapeutic equivalence of generic(s).. well established by the medicines authorities during the authorisation procedure, as demonstrated by extensive testing and documentation, and often by years of practical experience in treatment........................................... .......................................................................................................................... Indeed, the variation between different batches of an originator product is often of the same magnitude or even greater than the statistically calculated and controlled difference between a generic medicine and its reference product *.” European Generics Medicines Association Website http://www.egagenerics.com/gen-quality.htm9 *Meth. Find Exp. Clin. Pharmacol. 1989; 11:647-655
  10. 10. Complex Generic Drugs  Incomplete phyisco-chemcial comparability eg – Different Dosage form – Novel inactive ingredient – Different strength eg 0.5mL dosage of 20mg/mL instead of 1mL of 10mg/mL  Different administration route  Different usage  Improved bioavailability or site and duration of action (“supergeneric”)  Require more data than simple generics to support the safety and efficacy of the drug – Often animal studies and human clinical safety/efficacy  Increased, separate regulatory requirements “paper New Drug Application (NDA)”10  May not be clinically interchangeable with innovator drug
  11. 11. Example of Simple Generic Drug -Ondansetron C18H19N3O Mol. mass 293.4 Zofran® 4mg - GSK Generic ondansetron 4mg - Mylan • Active pharmaceutical ingredient patent expired around 2004 • simple defined molecule •11 generic competitors to innovator launched at market formation in 200411 • available across US, Europe and Australia Pharma & Biotech Innovation
  12. 12. Example of Biosimilar -Erythropoietin (EPO) •Glycoprotein, 165 aa, aprox. 30 kDa, single S-S bond •Peptide component ca 60%, complex carbohydrate component ca 40% •Complex glycan structures of individual molecules glycoisoforms •Defined mixture of glycovariants having the same amino acid backbone • patent expired around 2004 •Biosimilar forms of EPO available in EU • 5 generics approvals in EU (by 3 separate companies), 2 in AU •Based on complex chemical comparisons and PD (Pharmacodynamic) and12 PK (pharmacokinetic) comparisons with innovator drugs
  13. 13. Biosimilars – US Europe Comparison Note 4: USA Draft Guidelines issued in 201113 USA Updated/Final guidelines to be issued mid-2012
  14. 14. Biosimilars – Comparison with Simple Generic Drugs • Biosimilars are comparable to, not substitutable for innovator • Generics are equivalent to, and substitutable for innovator •Biosimilars - more extensive chemical comparability evidence than generics •Clinical studies • Biosimilars include PD as well as PK and sometimes clinical effectiveness (eg symptom reduction or perhaps overall survival) • Generics only require PK • Biosimilars much more expensive development pathway than generics •Generics can be substituted by clinician or pharmacist for innovator • Clinician needs evidence to substitute a Biosimilar for innovator • Generics can be marketed to wholesalers (compete on price), Biosimilars14 need marketing to clinicians (compete on price and effectiveness)
  15. 15. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-ap EMA and FDA to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/News/EMA US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimi EMA definitions of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/EM Generic applications in the EU, patents and exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/GeCare Act of 2010, Improving Access to Innovative Medical Therapies-Subtitle (Biologics Price Competition and Innovation Act of 2009, section 351(k), 351(l), 351(m). Pub.L.No.111-48. 2011. 3-2-2011.directions. Expert Opin Biol Ther. 2010;10:1011-8.of biosimilars: not only a cost issue. Oncologie. 2011;13(5):218-21. Generics – Market Size •The global generics market is estimated at about $225 billion in 2011. •By 2016, total global generics sector estimated at $358 billion, (more than 18% of all pharmaceuticals) •Projected compound annual growth rate (CAGR) of 9.7% between 2011 and 2016. Additional growth from emerging biosimilars market. • Emerging market (BRICs etc) represents the 2nd largest market for generic drugs $57 billion in 2011 growing to ca $115 billion in 2016 (CAGR of 15.1%) 15 Pharma & Biotech Innovation
  16. 16. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-ap EMA and FDA to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/News/EMA US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimi EMA definitions of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/EM Generic applications in the EU, patents and exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/GeCare Act of 2010, Improving Access to Innovative Medical Therapies-Subtitle (Biologics Price Competition and Innovation Act of 2009, section 351(k), 351(l), 351(m). Pub.L.No.111-48. 2011. 3-2-2011.directions. Expert Opin Biol Ther. 2010;10:1011-8.of biosimilars: not only a cost issue. Oncologie. 2011;13(5):218-21. Generics – Market Opportunity • Innovators expected to lose ca $100bn in sales 2011-2015 due to the “patent cliff” (expiring blockbuster drugs) •presents a significant opportunity for generics players • With increasing drug costs, governments increase generic use to contain costs •But generics companies also have increased pricing pressure. •Many leading generics companies are expanding globally •Often with vertical integration strategies • entering more complex generics areas & biosimilars •Innovator companies are entering the generics area (eg Novartis via Sandoz) •Also often with an authorised generic strategy • Strong focus on emerging markets which are characterized by high generics uptake and future growth potential. 16 Pharma & Biotech Innovation
  17. 17. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-ap EMA and FDA to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/News/EMA US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimi EMA definitions of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/EM Generic applications in the EU, patents and exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/GeCare Act of 2010, Improving Access to Innovative Medical Therapies-Subtitle (Biologics Price Competition and Innovation Act of 2009, section 351(k), 351(l), 351(m). Pub.L.No.111-48. 2011. 3-2-2011.directions. Expert Opin Biol Ther. 2010;10:1011-8.of biosimilars: not only a cost issue. Oncologie. 2011;13(5):218-21. Generics – Product lifecycle •When market opens to generics (usually at patent expiry), most drugs • are subject to intense competition with upwards of 10 companies entering the market (particularly blockbuster drugs ie >$1b sales) • Price falls dramatically immediately & in the first year (in US ca by 90%) • Innovators usually stop promoting innovator product •switch market to newer drugs • As a consequence total value and volume of sales of drug (innovator plus generics) drop substantially •A 4-5 year profitable lifecycle (with a long tail) is expected for generics (complex generics and biosimilars expected to be much longer) 17 Pharma & Biotech Innovation
  18. 18. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-ap EMA and FDA to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/News/EMA US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimi EMA definitions of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/EM Generic applications in the EU, patents and exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/GeCare Act of 2010, Improving Access to Innovative Medical Therapies-Subtitle (Biologics Price Competition and Innovation Act of 2009, section 351(k), 351(l), 351(m). Pub.L.No.111-48. 2011. 3-2-2011.directions. Expert Opin Biol Ther. 2010;10:1011-8.of biosimilars: not only a cost issue. Oncologie. 2011;13(5):218-21. Generics – Cost Advantages • Generics avoid the expensive clinical trials •average cost of discovering and testing a new innovative drug using a new chemical entity) as much as $800m (most costs in clinical phase) •generic total development cost $1-5 million, including <$1m on PK •Generics avoid large marketing costs • Generics equivalent to & substitutable for innovator • market to wholesalers not clinicians •Biosimilars require larger marketing costs 18 • Biosimilars comparable to but not substitutable for innovator •
  19. 19. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-ap EMA and FDA to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/News/EMA US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimi EMA definitions of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/EM Generics – Cost Pressures and Generic applications in the EU, patents and exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/GeCare Act of 2010, Improving Access to Innovative Medical Therapies-Subtitle (Biologics Price Competition and Innovation Act of 2009, section 351(k), 351(l), 351(m). Pub.L.No.111-48. 2011. 3-2-2011.directions. Expert Opin Biol Ther. 2010;10:1011-8.of biosimilars: not only a cost issue. Oncologie. 2011;13(5):218-21. Globalisation •Short lifecycle and cost sensitivity focus generic companies on •Time to market • Profit Margins (minimising cost of goods sold) • Minimising development $ • Trend towards vertically integrated generic companies with • API manufacturing facilities (often through company acquisition) • Drug product and packaging facilities • Global Marketing abilities • Location of facilities in cost competitive countries eg India and China • Generic Companies frequently developing drugs •Very quickly (12-14 months to submission) • Well before patent expiry 19 • Patent circumvention and challenges more common
  20. 20. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-ap EMA and FDA to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/News/EMA US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimil EMA definitions of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/EM Generic applications in the EU, patents and exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Reports/GeCare Act of 2010, Improving Access to Innovative Medical Therapies-Subtitle (Biologics Price Competition and Innovation Act of 2009, section 351(k), 351(l), 351(m). Pub.L.No.111-48. 2011. 3-2-2011.directions. Expert Opin Biol Ther. 2010;10:1011-8.of biosimilars: not only a cost issue. Oncologie. 2011;13(5):218-21. Generics – Intellectual Property Intellectual Property (IP) of innovator is in four forms • Published patents • API as a chemical entity (“substance patents”) • Salts, hydrates, enantiomers and other forms of the API • Process for synthesis of the API • Formulation of the drug product • Process for preparation of the drug product • Clinical use of the drug product • Trade Secrets • Not often used as most products can be reverse-engineered • Data disclosure required (eg FDA SBA; EU EPAR; and AU AUSPAR) •Data Exclusivity •Data collected for drug development including regulatory submissions • regulatory authorities refuse access to data to generics for a period 20 of time post submission by innovator (often 3-5 years)
  21. 21. Generics – IP Strategies 1. Wait for expiry of all relevant patents and data exclusivities 2.At expiry of data exclusivity challenge validity of unexpired innovator patents and lodge application for approval of generic 3.At expiry of data exclusivity lodge an application for a drug product which does not infringe unexpired innovator patents 4.Potential for non-infringing drug products to create IP for generic company 5.In US first generic to file for a product ahead of patent expiry gets 6 months exclusivity21 Pharma & Biotech Innovation
  22. 22. Innovator IP Strategies 1.Evergreening – in addition to patent on API • Patents for salts, hydrates and enantiomers • Need to be clinically significantly different to be effective • Patents for other dosage forms and formulations • eg controlled release dosage forms • Introduce new product just prior to expiry of standard product • Patents for process of manufacture of API • Patents for clinical use • GSK held patents for all these areas for Ondansetron 2.Authorised Generic • Innovator allows market access to generic company under license • May even sell innovator product in different packaging 3.Marketed Generic • Innovator markets its own generic product • May continue to market own innovator branded product also22
  23. 23. Position of Generics in Health Care •Innovator Companies charge higher prices for drugs during period of patent and data exclusivity • Recoups cost of development and clinical trials • Ensures ongoing profitability and further investment in new drugs •After patent and exclusivity expiry competition leads to the fall in the cost of drugs to close to the cost of manufacture plus margin23
  24. 24. Position of Generics in Health Care •Generics make Affordable Medicines available to public • Generic drugs save EU over €25 b and US $150b each year • Close to 50% of all medicines in Europe are generics • Competition from generic medicines provides incentive to originator companies to develop innovative products. • Savings from using generics help governments and patients to pay for the costly new innovative drugs and treatments.24
  25. 25. Generic Drugs 3rd Year lecture in the “Biotechnology in Practice” course, University of Melbourne May 2012 Michael McNamara MSc MRACI C Chem Pharma & Biotech Innovation ph 03 94997193 mobile 040771376825 michael.mcnamara@live.com.au PBI

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