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Generic Drugs

New Dynamics and Challenges in The Generics Market 2007

 

Publication Date January 2007
Publisher Scrip Reports
Product Type Report
Pages not applicable
ISBN Number not applicable
Product Code SCR00016

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Summary

The economic cost of cardiovascular disease (CVD) and stroke, a potential consequence of CVD, is of staggering proportions, estimated by the American Heart Association and the National Heart, Lung, and Blood Institute to be $403.1 billion in 2006. As a result of such high demand the cardiovascular segment is one of the most fiercely fought over by medical device companies which are investing heavily in device-based therapies that have the capability to cost effectively treat CVD patients.

Competition between medical device companies in the market is increasingly intense and as a consequence merger and acquisition activity rose dramatically in the sector in 2006 and has continued into 2007. Part of this rise can be attributed to an expanding US economy, increases in corporate profits and stock prices, technological improvements, and growing product demand. The large cardiovascular deals in 2006 were Boston Scientific taking Guidant in a landmark $27 billion deal, the acquisition of Guidant's vascular and endovascular businesses by Abbott for $4.1 billion and J&J's purchase of stent maker Conor Medsystems for $1.4 billion.

However there have been a number of smaller but also significant deals such as ATS Medical, in a bid to flesh out its cardiac surgery product line, acquiring 3F Therapeutics, an early-stage company specialising in minimally-invasive, beating heart tissue valve replacements, and, in 2007 acquiring the surgical cryoablation business of CryoCath Technologies.

The two big sectors of the cardiovascular market where there are the most valuable markets to conquer are coronary stents and cardiac rhythm management devices.

Following balloon angioplasty procedures, approximately 30% of coronary arteries are affected by this complication. The launch of bare metal coronary stents in the 1990s went some way towards alleviating this problem but the bare metal stents continue to be associated with a restenosis rate of around 25% of patients being affected six months after stent insertion. Drug eluting stents attracted increasing attention during the 1990s as potentially offering a more effective way to lower the rate of restenosis to single figures. Drug eluting stents (DES) have certainly made their mark with the value of the US market alone rising from $1.1 billion in 2004 to $3.1 billion in 2006. Cordis' Cypher stent was released in the European and US markets in 2003 and Boston Scientific entered the European market in 2003 and the US market in March 2004 with the Taxus stent. This product allowed Boston Scientifc to successfully challenge Cordis, gaining market share overall and winning approximately two thirds of the US market in its first year of launch.

These two companies, Cordis and Boston Scientific remain locked in a battle for dominance of the drug eluting stent market. Both companies however suffered setbacks from product recalls and this had a strong effect on the market, causing a fall in use. In addition some recent long-term studies have suggested that there has been overuse of DES, which again may affect DES utilisation rates. Factors which will buoy the market up are new stent designs that create a balance between low profile, flexibility, ease of deployment and sufficient endoluminal surface coverage. Newer alloys such as cobalt chromium are helping fulfil these design goals. Two new stents on the market use this alloy: the Xience V everolimus-eluting coronary stent system of Abbott Vascular and the Endeavor stent of Medtronic. Both of these have received European approval and are awaiting US market authorisation. When these do hit the US market, however, their impact is forecast to be significant. Results from the SPIRIT series of trials, for example, suggest that the Xience V is slightly more effective than the Taxus stent. This in combination with the fact that some cardiologists, due to product recalls, have become a little wary of the DES of J&J and Boston Scientific and that, despite certain contract tie-ins to particular companies, cardiologists are ever seeking to try new more cost-effective products, will assure Abbott and Medtronic a warm welcome onto the market.

Just as there has been consolidation in the stent market this has also occurred in the cardiac rhythm management (CRM) sector and three companies: Medtronic, Boston Scientific and St Jude Medical hold approximately 90% of the market share.

The pacemakers market was also impacted by device recalls in 2005 and while the overall world CRM market grew by 3%, the US market declined in 2005 compared to 2004. Even companies that did not have any device recalls reported a year-over-year loss in total pacemaker sales for 2005.

This dip in the market can be directly related to an oversaturated market combined with a loss of consumer confidence due to electrostimulation device recalls. Medtronic, Guidant, and St Jude Medical all announced potential defects in certain models. Medtronic recalled about 87,000 ICDs because of evidence that the batteries might fail. Guidant recalled about 50,000 ICDs for possible malfunctions, including a short-circuiting flaw and also reported a faulty switch problem that might impair the function of another 45,000 ICDs. St. Jude Medical reported a software problem that could lead to a malfunction in 39,000 ICDs and recalled about 28,000 pacemakers because of a potentially defective seal that could leak and allow moisture to enter the devices. Such recalls have prevented ICD manufacturers from capitalising on its new era of expanded reimbursement coverage.

Considering that pacemakers have functioned like clockwork with minimal safety concerns, most physicians expected the same from lCD devices as well, but the recent events forced them to go back and re evaluate these devices based on clinical trial and performance reports. A major help was that in 2005 the European Society of Cardiology update of Guidelines for the diagnosis and treatment of chronic heart failure for the first time, made formal recommendations on the use of device therapy for patients with moderate to severe heart failure. In light of compelling evidence demonstrating the benefits of implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy (CRT), these guidelines recommended that these devices be considered as standard-of-care in appropriate patients. Despite such recommendations recovery has been slow but, in 2007, companies were reporting an upturn in fortunes. St Jude Medical, for example stated that its fourth-quarter sales of ICDs totaled

$289 million, which was toward the upper end of its expectations. St Jude, which previously warned of a slowdown in the heart device market, said it now expects earnings of about 42 cents a share for the fourth quarter having previously forecast 38 cents to 40 cents a share.

Although not as large as the vascular intervention or CRM markets a sector that is gaining a lot of attention is the artificial heart valve market. There are two main types of artificial heart valves: mechanical and tissue valves or bioprostheses. Whereas bioprostheses do not require anticoagulation, they are not as durable as mechanical valves. On average, structural tissue valve degeneration occurs between 10 and 15 years after implantation (depending on patient age at the time of implantation). These valves are usually used for elderly patients whose life expectancies are less than the life span of a bioprosthesis. Another indication for its use includes younger patients in whom the use of anticoagulation is contraindicated. However, with the increasing popularity of minimally invasive valve surgery, and the improved results in valve reoperations, many younger patients choose to have a bioprosthesis. These patients believing that the risk of a second heart operation outweighs the risk of long-term anticoagulation and its associated lifestyle limitations. As a consequence of such factors the tissue valve market has been experiencing strong growth whilst the mechanical valve market appears to have descended into permanent decline. Both types of artificial heart valve markets are, however, being adversely affected by the growing efficiency of heart valve repair technologies.

Valve repair is the procedure of choice for most patients with valve disease as opposed to valve replacement because the long term outcomes are superior with repair. In certain instances, like rheumatic heart disease, the valve is so severely damaged that replacement is performed, but valves can be repaired rather than replaced in 95% of patients and the surgical risk is generally less than 1 in 1,000 and new minimally invasive techniques have the potential to decrease this even further. One such technology is the Monarc system of Edwards Lifesciences for treating mitral valve regurgitation. In April 2007 results from 59 patients implanted with the device revealed a 30-day event-free survival of 91.4%, and no deaths related to the procedure. The Monarc system consists of two stent-like anchors that are connected by a spring bridge, and a biodegradeable element within the bridge. Mounted on a catheter, the device is threaded into the coronary sinus, a vein in the heart that runs next to the annulus, which defines the opening of the mitral valve. The anchors are implanted in separate positions in the coronary sinus, so that the metal bridge surrounds a significant portion of the mitral valve annulus. Over several weeks, the bridge shortens, creating tension around the mitral valve, gradually reshaping the leaflets and surrounding structures, and, thereby, resulting in improved leaflet function and reduced mitral regurgitation.

This report examines the impact of new technologies and the growth of the various sectors of the cardiovascular device market in addition to describing the main geographical markets and the emerging ones such as India, South East Asia, China, which, due to their rapid economic growth are attracting the attention of market players of all sizes. However gaining access to a market with a novel or even a "me too" cardiovascular device is no easy procedure as, in addition to being costly products to reimburse, they frequently fall into the highest of the risk class of devices and the report therefore examines the barriers and procedures required for entering these markets.

Contents

  • Chapter 1 Innovation and Access: The Legacy of The Trips Agreement
    • 1.1 The Origins of Trips
    • 1.2 What Trips Did
    • 1.3 before and after Trips
    • 1.4 The Consequences of Trips
    • 1.4.1 Proprietary Rights and Public Health
    • 1.4.2 Brazil - Conflicts
    • 1.5 Data Exclusivity
    • 1.5.1 Article 39.3: Open to Interpretation
    • 1.6 The Patent Effect
    • 1.6.1 India and Aids Therapies
    • 1.6.2 Other Countries and Therapies
    • 1.7 What's in The Box?
    • 1.7.1 Generics Concession
    • 1.8 Novartis' Legal Challenge
    • 1.9 A Step Further
    • 1.10 Difficult Comparison
    • 1.10.1 Unravelling Aids Drug Prices
    • 1.11 Different Priorities
    • 1.12 Sanofi-Aventis' Asaq Concession
    • 1.12.1 Control Strategy?
    • 1.13 The Bigger Picture
  • Chapter 2 The Road to Doha
    • 2.1 The Bolar Exemption
    • 2.2 Compulsory Licensing Draws Blood
    • 2.2.1 Compulsory Licensing: Already Exploited
    • 2.2.2 The South African Aids Case
    • 2.3 Trips Agreement and Public Health
    • Parallel Imports
    • Compulsory Licences
    • Differential Pricing
    • Protection of Test Data
    • Transitional Arrangements
    • 2.3.1 The US and Eu's View
    • 2.4 The Doha Declaration
    • Parallel Imports
    • Transition Periods
    • Compulsory Licensing
    • 2.4.1 Declaration on The Trips Agreement and Public Health
  • Chapter 3 Trouble with Paragraph
    • 3.1 Back to The Barricades
    • 3.1.1 The Motta Text
    • 3.2 The 30 August Decision
    • 3.3 The 30 August Provisions
    • 3.3.1 Conditions for Compulsory Licensing
    • 3.4 Double Trouble
    • 3.4.1 Anti-Diversion Efforts
    • 3.5 Economies of Scale
  • Chapter 4 in The Wake of Doha
    • 4.1 Loose Ends
    • 4.1.1 Rwanda Sets The Precedent
    • 4.2 Mixed Result in Canada
    • 4.2.1 Canada's Limited List
    • 4.3 The Eu Regulation
    • 4.3.1 Parliament's Response
    • 4.4 The Political Debate over Ratification
    • 4.4.1 Parliament Dissents
    • 4.5 The Fta Threat
    • 4.5.1 Contrary to Doha?
    • Delayed Approval of Generic Drugs
    • Required Patent Extensions
    • Linked Drug Approvals to Patent Status
    • Restricted Compulsory Licensing
    • Prohibited Parallel Imports
    • Expanded Patent Protection
    • 4.6 US Generic Resistance
    • 4.6.1 Pressure on Guatemala
    • 4.6.2 New Trade Policy for America
    • 4.6.3 Industry Responses
    • 4.6.4 Newly Signed Ftas
    • 4.6 More Clashes over Compulsory Licensing
    • 4.6.1 Thailand and Compulsory Licensing
    • 4.6.2 A Political Rift in Europe
    • 4.6.3 Brazil and Compulsory Licensing
    • 4.6.4 A "chilling Signal"
    • 4.6.5 The Philippine Situation
    • 4.7 Living with Patents
    • in China
    • in India
    • 4.8 India Abroad
    • 4.9 Tough Enough for The US?
    • 4.9.1 Dr Reddy's Amvaz Setback
    • 4.9.2 Staying Power?
  • Chapter 5 New Opportunities, New Restraints in The US Market
    • 5.1 A Solid Foundation
    • 5.2 Consolidation Abounds
    • 5.3 Increasing Sales
    • 5.4 Pricing Issues
    • 5.4.1.1 Vertical Integration
    • 5.4.2 Optimism about US Pricing
    • 5.5 A Healthy Future?
    • 5.6 The Generic Rationale
    • 5.6.1 The Impact of Medicare
    • 5.6.2 Muted Effect
    • 5.6.3 Generics Will Benefit
    • 5.7 Drug Pricing Debate Persists
    • 5.5 Wal-Mart's $4 Generic Offer
  • Chapter 6 How Medicare Reform Eased Generic Access in The US
    • 6.1 Modernising for Generics
    • The 180-Day Marketing Exclusivity
    • The 30-Month Stay
    • 6.1.1 Strategic Alternative
    • 6.1.2 The Ftc's Findings
    • 6.1.3 The Ftc's Recommendations
    • 6.2 Legislative Responses
    • 6.3 The Fda Steps in
    • 6.3.1 The Fda's Final Rule
    • 6.3.2 Speeding up Generic Approvals
    • 6.4 Legal Back-up 30-Month Stays
    • Declaratory Judgments 180-Day Exclusivity
    • Counterclaims
    • Notification of Settlements
    • Bioequivalence
    • Anti-Bundling
    • 6.4.1 Fda's Guidance for Industry
    • 6.5 Widening The Gap
    • Try Again
  • Chapter 7 Bad Moon Rising: New Strategies to Slow Generic Entry in The US
    • 7.1 Looking at Medicaid
    • 7.2 The Patent Bounty
    • 7.3 Case Study: Simvastatin
    • 7.3.1 Enter Sandoz
    • 7.3.2 Enter Dr Reddy's
    • 7.3.3 "legal Bribes"?
    • 7.4 US Battle Not over
    • 7.4.1 Medicaid Again
    • 7.4.2 Final Rule on Drug Price Reporting
    • 7.4.3 Pharmacists Hit
    • 7.5 Authorising Authorised Generics
    • Accelerating Trend
    • 7.5.1 Playing Both Sides of The Fence
    • 7.5.2 Undermining The 180-Day Exclusivity
    • 7.5.3 The Ftc's Study of Authorised Generics
    • 7.5.3.1 Delayed Action
    • 7.5.4 Pricing Impact
    • Gpha Begs to Differ
    • 7.5.5 A Legal Remedy?
    • No Legal Basis
    • 7.5.6 Bills S. 438 and H.R
    • 7.6 Not So Exclusive
    • 7.6.1 Multiple First Applicants
    • 7.6.2 The Paxil Judgement
    • 7.7 The First-to-File System - Apotex Calls for An Overhaul
    • 7.8 Patent Settlements under The Spotlight
    • 7.8.1 The Reverse-Payment Investigation
    • No Headway for The Ftc
    • 7.8.2 The Preserve Access to Affordable Generics Act
    • 7.8.3 More Congressional Action
    • Not in Your Interests
    • A Lenient View
    • 7.9 Case Study: Plavix
    • An Unusual Series of Events
    • 7.9.1 A Tentative Agreement
    • 7.9.2 Strategic Blunder
    • Valid and Enforceable
    • 7.10 More about Citizen Petitions
    • 7.10.1 A Bifurcated System
    • 7.10.2 The Fda Revitalization Act
    • 7.11 More Trouble with Patents
    • 7.11.1 First to Invent or to File?
    • 7.11.2 Best Mode Requirement
    • 7.11.3 Start with The Uspto
    • 7.12 The Perils of Biodefence
    • Strong Reservations
    • 7.12.1 A Comfortable Compromise
    • 7.13 Clearing The Backlog
    • 7.13.1 Api Suppliers - Choose Carefully
    • 7.13.2 The Benefits of User Fees
    • 7.14 towards A Generic Drug User-Fee Programme
    • 7.14.1 Not A Magic Bullet
    • 7.14.2 Ogd Is "overworked"; "overwhelmed"
    • 7.14.3 No Programme Yet
    • 7.15 on The Fast Track for 'first Generics' and Others
  • Chapter 8 More Questions than Answers in Europe
    • 8.1 Everything Changes
    • 8.2 The Eu: A Singular Not Single Market
    • 8.3 Factors for Growth
    • 8.3.1 Critical Outcomes of The Pharmaceutical Review
    • 8.3.2 The Impact of An Aging Population
    • 8.3.3 The Cost Saving Effect
    • 8.3.4 The Impact of Patent Expiries
    • 8.4 More on Cost-Containment and Pricing Pressure
    • 8.4.1 A New Pricing Paradigm
    • 8.5 Back to The Pharmaceutical Review: A Fair Compromise?
    • 8.5.1 Advances for The Generics Industry?
    • 8.5.2 Data Exclusivity Provisions: A Difficult Birth
  • Chapter 9 Europe: How IT All Works
    • 9.1 Data Exclusivity
    • 9.1.1 Explaining Eight plus Two plus One
    • 9.2 Defining "significant Clinical Benefit"
    • 9.3 The Cost of The Eight plus Two plus One Compromise
    • 9.4 against Data Exclusivity
    • Who Owns The Data?
    • Back Door to Market Protection
    • 9.5 Compensations of The Legislation
    • 9.5.1 Derogations from Eight plus Two plus One
    • 9.6 More 'plus Ones'
    • What Is 'well-Established'?
    • 9.6.1 Data Exclusivity for Otc Switches
    • 9.6.2 National Complications
    • 9.7 Global Marketing Authorisation - A Win for Generics
    • 9.7.1 Court Back-up
    • 9.8 Defining Generics
    • 9.9 The European Reference Product
    • 9.9.1 The Ecj's Verdict on Generics UK/Losec
    • 9.9.2 Creative Product Removal
    • 9.9.3 Backdating European Reference Products
  • Chapter 10 Europe: How IT All Works (Part 2)
    • 10.1 What Bolar Allows
    • 10.1.1 The Experimental-Use Exemption
    • 10.1.2 Disparity with The US Bolar Clause
    • 10.1.3 Europe's Bolar Variations
    • 10.1.3.1 UK Bolar
    • 10.1.3.2 German Bolar
    • 10.1.3.3 Italian Bolar
    • 10.1.4 Stockpiling - Another Grey Area
    • 10.2 Bolar: A Back Door to Patent Linkage?
    • 10.2.1 Isolated Case
    • 10.3 A European Patent Solution?
    • 10.3.1 The Epla Solution
    • 10.3.2 An Integrated Approach
    • The Language Barrier
    • 10.4 Some Harmony in Smpcs
    • 10.4.1 Usage Patents
    • 10.4.2 'carving out'
    • 10.5 The Name Game
    • 10.5.1 Different Generic Names
    • 10.6 Marketing Authorisation: Which Route to Take?
    • 10.6.1 The European Commission's Draft Guideline
    • 10.6.2 The Emea's Draft Guidance
    • 10.6.3 The 'old' and 'new' Mrp
    • 10.6.4 Guideline on "serious Risks to Public Health"
    • 10.6.5 What The Decentralised Route Offers
    • "exceeded All Our Expectations"
    • 10.7 Case Study: Zalasta Goes Central
    • 10.8 The 'sunset Clause'
    • 10.9 What's More... Criminal Measures and Paediatric Use
    • 10.9.1 Ipred Ii
    • One Size Fits All
    • Catching Dolphins in Tuna Nets
    • 10.9.2 Patents Excluded
    • 10.9.2.1 Excessive Patenting and The Decline of
    • Innovation
    • 10.9.3 Medicines for Children
    • 10.9.3.1 Six-Month Extension
    • 10.9.3.2 Safeguarding against 'double Rewards'
    • Contents New Dynamics and Challenges in The Generics Market, 2007
    • Informa UK Ltd, 2007 6 Www.Scripreports.Com
    • Photocopying & Distribution of This Document Is Illegal
    • 10.9.3.3 Access to Data
    • 10.9.3.4 Funding for Paediatric Use of off-Patent
    • Medicines
  • Chapter 11 Europe: on The Ground
    • 11.1 after The Review
    • 11.1.1 Call for More Aggressive Incentives
    • 11.1.1.1 The Portuguese Example
    • 11.2 The Impact of P&r
    • 11.2.1 Automatic Reimbursement
    • 11.2.2 Degrees of Switching
    • 11.2.3 Price Linkage
    • 11.3 Market Conditions
    • 11.3.1 Generic Pricing and Reimbursement
    • 11.3.2 Patient Co-Payments
    • 11.3.3 Generic Prescribing
    • 11.3.4 Generic Substitution
    • 11.3.5 Marketing Authorisation
    • 11.4 Sustaining Generics Medicines Markets
    • 11.4.1 The Need for Demand-Side Measures
    • The Advantages of (Relatively) Free Pricing
    • 11.4.1.1 Germany
    • 11.4.1.2 France
    • 11.4.1.3 Italy
    • 11.4.2 Kul Recommendations for A Competitive Generic
    • Medicines Market
    • Introduce A Coherent Generic Medicines Policy
    • Encourage Price Differentiation/Competition within
    • Existing Regulatory Frameworks
    • Disseminate Pricing Information to The Relevant
    • Players
    • Increase Confidence in Generic Medicines
    • Provide Incentives for Doctors to Prescribe Generic
    • Medicines
    • Remove Financial Disincentives for Pharmacists to
    • Dispense Generic Medicines
    • Provide Incentives for Patients to Demand Generic
    • Medicines
    • 11.5 Mixed Messages for The Generics Industry
    • 11.5.1 The Portuguese Campaign
    • 11.5.2 Denmark Questions Safety Benefits
    • 11.5.3 Hungary: Little Interest in Generic Substitution
    • 11.5.4 Germany: Opportunities Squandered and Health Reforms
    • 11.5.5 Aok Discounts Criticised
    • Stada to Win
    • A Template for Markets Worldwide
  • Chapter 12 The Japanese Lag
    • 12.1 A Positive Future for Generics?
    • 12.1.1 Dispelling Doctors' Concerns
    • 12.1.2 Corporate Optimism
    • 12.1.3 Remaining Challenges
    • 12.1.4 A Breakthrough on Substitution
    • Contents New Dynamics and Challenges in The Generics Market, 2007
    • Informa UK Ltd, 2007 7 Www.Scripreports.Com
    • Photocopying & Distribution of This Document Is Illegal
    • 12.1.5 Pricing Progress
    • 12.1.6 Data Protection Concessions
    • 12.1.7 Squeezing Research- Based Companies
    • 12.1.8 More Positive Signals
  • Chapter 13 beyond Compare? - Clearing A Path for Biosimilars
    • 13.1 Biogenerics: Uncertainty Rules
    • 13.1.1 Debate over Definitions
    • 13.1.2 An Uncertain Regulatory Pathway
    • 13.1.3 Other Counties Lead The Way
    • 13.2 Market Potential - Varied Predictions
    • 13.2.1 The Drivers of Biogenerics
    • 13.2.2 The US Market Potential
    • 13.2.3 The Issue of Cost
    • 13.2.3.1 Potential - but Only in The Long Term
    • "petrified of The Biotech Lobby"
    • 13.3 Epo and The Emerging Eu Biosimilars Market
    • 13.3.1 The Importance of The Inn
    • 13.3.2 Looking Back... A Bumpy Ride for Alpheon
    • 13.4 Comparatively Difficult
    • Product and Process
    • 13.4.1 The Power of Analytical Tools
    • 13.5 Data: How Much Is Enough?
    • A Hybrid Approach
    • 'essential Similarity' Put to Bed
    • 13.5.1 'top Ten' Conclusions on The Eu Comparability Guidelines
    • 13.6 The Interchangeability Debate
    • A Matter of Clinical Practice
    • 13.7 What's in A Name? (Inns)
    • 13.7.1 Reviewing The Nomenclature
    • 13.7.2 Similar but Not Identical? Efpia and Ebe's Approach
    • under The Guise of Safety
    • 13.7.3 Fda Rejects Distinct Inns for Biosimilars
    • 13.7.4 Biotech and Generics Both Claim Victory
    • 13.7.5 No Immediate Threat to The Use of Common Inns
    • 13.8 The US: A Regulatory Void
    • 13.8.1 Problems with Section 505 (B) (2)
    • An "uncompensated Taking of Property"
    • 13.8.1.1 The Fda Delays on Omnitrope
    • Waxman Calls for Action
    • 13.9 Case Study: Looking Back at The Omnitrope Conundrum
    • 13.9.1 Omnitrope in Europe
    • 13.9.2 and in The US
    • 13.10 The Push for US Legislation
    • 13.10.1 The Long Wait for Guidelines
    • 13.10.2 The Fda's White Paper
    • Fda: Waiting for Legislators
    • 13.10.3 A Biosimilars Solution?
    • Echoes of Hatch-Waxman
    • 13.10.4 A Platform for Negotiations
    • 13.10.5 Political Compromise in Sight?
    • 13.10.5.1 The Lack of Clinical Studies Requirements
    • Inappropriate Assumptions of "sameness"
    • A Balanced Position
    • Contents New Dynamics and Challenges in The Generics Market, 2007
    • Informa UK Ltd, 2007 8 Www.Scripreports.Com
    • Photocopying & Distribution of This Document Is Illegal
    • 13.10.5.2 The Patient Protection and Innovative
    • Biologic Medicines Act / The Affordable Biologics for
    • Consumers Act of 2007
    • 13.10.5.3 An Acceptable Compromise: The Biologics
    • Price Competition and Innovation Act
    • "better than The European Biosimilar Language" 12 Years' Protection
    • 13.10.5.4 No Mention of Biosimilars
    • The Impact of The Presidential Election
    • 13.11 What's next for Biosimilars?
    • Reined in
  • Chapter 14 New Generic Paradigms: Challenges and Opportunities
    • 14.1 Research-Based Companies on The Defence
    • 14.1.1 The Obsolescence of Biotechnology Products
    • 14.1.2 New Formulations and Novel Combinations
    • 14.1.3 Patent Defence Strategies
    • 14.1.3.1 The Pfizer Example
    • 14.1.4 Rx to Otc Switching - on Both Sides
    • 14.2 Less to Copy: The R&d Productivity Issue
    • 14.3 Doing IT for Themselves: R&d Companies Move into Generics
    • 14.4 Supergenerics and More
    • 14.4.1 Teva's Nces
    • 14.4.2 Apotex's Nce
    • 14.4.3 Mixed Success for Andrx and Mylan
    • 14.5 Consolidation Bites
    • 14.5.1 Tapping into Apis
    • 14.5.2 Teva, Sandoz and after
    • 14.6 Consolidation Case Studies
    • 14.6.1 Barr/Pliva
    • 14.6.2 Mylan/Merck
    • 14.6.3 Actavis Privatisation
    • 14.7 Looking to The Future
    • 10.9.2.1 Excessive Patenting and The Decline of
    • Innovation
    • 10.9.3 Medicines for Children
    • 10.9.3.1 Six-Month Extension
    • 10.9.3.2 Safeguarding against 'double Rewards'
    • 10.9.3.3 Access to Data
    • 10.9.3.4 Funding for Paediatric Use of off-Patent
    • Medicines
  • Chapter 11 Europe: on The Ground
    • 11.1 after The Review
    • 11.1.1 Call for More Aggressive Incentives
    • 11.1.1.1 The Portuguese Example
    • 11.2 The Impact of P&r
    • 11.2.1 Automatic Reimbursement
    • 11.2.2 Degrees of Switching
    • 11.2.3 Price Linkage
    • 11.3 Market Conditions
    • 11.3.1 Generic Pricing and Reimbursement
    • 11.3.2 Patient Co-Payments
    • 11.3.3 Generic Prescribing
    • 11.3.4 Generic Substitution
    • 11.3.5 Marketing Authorisation
    • 11.4 Sustaining Generics Medicines Markets
    • 11.4.1 The Need for Demand-Side Measures
    • The Advantages of (Relatively) Free Pricing
    • 11.4.1.1 Germany
    • 11.4.1.2 France
    • 11.4.1.3 Italy
    • 11.4.2 Kul Recommendations for A Competitive Generic
    • Medicines Market
    • Introduce A Coherent Generic Medicines Policy
    • Encourage Price Differentiation/Competition within
    • Existing Regulatory Frameworks
    • Disseminate Pricing Information to The Relevant
    • Players
    • Increase Confidence in Generic Medicines
    • Provide Incentives for Doctors to Prescribe Generic
    • Medicines
    • Remove Financial Disincentives for Pharmacists to
    • Dispense Generic Medicines
    • Provide Incentives for Patients to Demand Generic
    • Medicines
    • 11.5 Mixed Messages for The Generics Industry
    • 11.5.1 The Portuguese Campaign
    • 11.5.2 Denmark Questions Safety Benefits
    • 11.5.3 Hungary: Little Interest in Generic Substitution
    • 11.5.4 Germany: Opportunities Squandered and Health Reforms
    • 11.5.5 Aok Discounts Criticised
    • Stada to Win
    • A Template for Markets Worldwide
  • Chapter 12 The Japanese Lag
    • 12.1 A Positive Future for Generics?
    • 12.1.1 Dispelling Doctors' Concerns
    • 12.1.2 Corporate Optimism
    • 12.1.3 Remaining Challenges
    • 12.1.4 A Breakthrough on Substitution
    • 12.1.5 Pricing Progress
    • 12.1.6 Data Protection Concessions
    • 12.1.7 Squeezing Research- Based Companies
    • 12.1.8 More Positive Signals
  • Chapter 13 beyond Compare? - Clearing A Path for Biosimilars
    • 13.1 Biogenerics: Uncertainty Rules
    • 13.1.1 Debate over Definitions
    • 13.1.2 An Uncertain Regulatory Pathway
    • 13.1.3 Other Counties Lead The Way
    • 13.2 Market Potential - Varied Predictions
    • 13.2.1 The Drivers of Biogenerics
    • 13.2.2 The US Market Potential
    • 13.2.3 The Issue of Cost
    • 13.2.3.1 Potential - but Only in The Long Term
    • "petrified of The Biotech Lobby"
    • 13.3 Epo and The Emerging Eu Biosimilars Market
    • 13.3.1 The Importance of The Inn
    • 13.3.2 Looking Back... A Bumpy Ride for Alpheon
    • 13.4 Comparatively Difficult
    • Product and Process
    • 13.4.1 The Power of Analytical Tools
    • 13.5 Data: How Much Is Enough?
    • A Hybrid Approach
    • 'essential Similarity' Put to Bed
    • 13.5.1 'top Ten' Conclusions on The Eu Comparability Guidelines
    • 13.6 The Interchangeability Debate
    • A Matter of Clinical Practice
    • 13.7 What's in A Name? (Inns)
    • 13.7.1 Reviewing The Nomenclature
    • 13.7.2 Similar but Not Identical? Efpia and Ebe's Approach
    • under The Guise of Safety
    • 13.7.3 Fda Rejects Distinct Inns for Biosimilars
    • 13.7.4 Biotech and Generics Both Claim Victory
    • 13.7.5 No Immediate Threat to The Use of Common Inns
    • 13.8 The US: A Regulatory Void
    • 13.8.1 Problems with Section 505 (B) (2)
    • An "uncompensated Taking of Property"
    • 13.8.1.1 The Fda Delays on Omnitrope
    • Waxman Calls for Action
    • 13.9 Case Study: Looking Back at The Omnitrope Conundrum
    • 13.9.1 Omnitrope in Europe
    • 13.9.2 and in The US
    • 13.10 The Push for US Legislation
    • 13.10.1 The Long Wait for Guidelines
    • 13.10.2 The Fda's White Paper
    • Fda: Waiting for Legislators
    • 13.10.3 A Biosimilars Solution?
    • Echoes of Hatch-Waxman
    • 13.10.4 A Platform for Negotiations
    • 13.10.5 Political Compromise in Sight?
    • 13.10.5.1 The Lack of Clinical Studies Requirements
    • Inappropriate Assumptions of "sameness"
    • A Balanced Position
    • 13.10.5.2 The Patient Protection and Innovative
    • Biologic Medicines Act / The Affordable Biologics for
    • Consumers Act of 2007
    • 13.10.5.3 An Acceptable Compromise: The Biologics
    • Price Competition and Innovation Act
    • "better than The European Biosimilar Language" 12 Years' Protection
    • 13.10.5.4 No Mention of Biosimilars
    • The Impact of The Presidential Election
    • 13.11 What's next for Biosimilars?
    • Reined in
  • Chapter 14 New Generic Paradigms: Challenges and Opportunities
    • 14.1 Research-Based Companies on The Defence
    • 14.1.1 The Obsolescence of Biotechnology Products
    • 14.1.2 New Formulations and Novel Combinations
    • 14.1.3 Patent Defence Strategies
    • 14.1.3.1 The Pfizer Example
    • 14.1.4 Rx to Otc Switching - on Both Sides
    • 14.2 Less to Copy: The R&d Productivity Issue
    • 14.3 Doing IT for Themselves: R&d Companies Move into Generics
    • 14.4 Supergenerics and More
    • 14.4.1 Teva's Nces
    • 14.4.2 Apotex's Nce
    • 14.4.3 Mixed Success for Andrx and Mylan
    • 14.5 Consolidation Bites
    • 14.5.1 Tapping into Apis
    • 14.5.2 Teva, Sandoz and after
    • 14.6 Consolidation Case Studies
    • 14.6.1 Barr/Pliva
    • 14.6.2 Mylan/Merck
    • 14.6.3 Actavis Privatisation
    • 14.7 Looking to The Future
  • List of Tables
    • Table 1.1 Cder New Drug Applications Approved in Calendar Years 1990-2004 by Therapeutic Potential and Chemical Type
    • Table 2.1 Generic- and Cost-Friendly Provisions in The Trips Agreement
    • Table 5.1 US Patent Expiries, 2007-200997
    • Table 5.2 Health, Education and Defence Spending as A Share of US Gdp, 1995-2005
    • Table 7.1 Top Ten US Generic Products by Sales, 2004
    • Table 8.1 Generic Market Shares in Europe by Value and Volume, 2006
    • Table 8.2 Sales Volumes for Newly Available Generics in The Four Largest European Markets, 2008-2012
    • Table 10.1 Bolar Implementation Status in Europe as of February 2006
    • Table 13.1 Blockbuster Biotechnology Products That Faced Patent Expiry before 2007 Figure 1.1 Price Impact of Switching to Improved First-Line Combinations for Hiv/Aids
    • Figure 5.1 Impact of Consolidation in The US Generics Market
    • Figure 5.2 Change in Price of Average Generic Drug Prescription, 2002-2004
    • Figure 5.3 Prescription Drugs as A Share of US Healthcare Spending, 1960-2005
    • Figure 6.1 Anda Patent Certification Options
    • Figure 6.2 Paragraph Iv Certification Options
    • Figure 7.1 Average Annual Sales of Branded Drugs Losing Patent Protection, 2005-2009
    • Figure 7.2 Dollar Value of Drugs Losing Patent Protection in The US, 1995-2010
    • Figure 9.1 How Data Exclusivity Rules Affect Generic Medicines
    • Figure 11.1 Time Delays for Pricing and Reimbursement Approval in Europe after The Granting of A Marketing Authorisation
    • Figure 13.1 US Pharmaceutical Market by Product Type, 1999-2009
    • Figure 14.1 Differentiating Factors for Hard-to-Make Generics