Generics: Regulatory Update
Generics: Regulatory Update
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Regulatory measures continue to shape the generics landscape. Cost-containment strategies continue to impact generics.
Publisher: Datamonitor Healthcare
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Regulatory measures continue to shape the generics landscape.
Cost-containment strategies continue to impact generics. Also controversy remains over the use of pay-for-delay deals in US, while user fees and new bioequivalence guidelines will both benefit and hinder the industry. However, greater collaboration between countries in terms of GMP certification and free trade agreements will benefit the generics players, particularly in emerging markets.
Features and benefits
- An overview of the impact of cost containment strategies on the generics industry.
- An examination of how the introduction of International Non-proprietary Name (INN) prescribing in certain markets will drive generic uptake.
- A review of attitudes towards pay-for-delay deals in the EU and US.
- An overview of regulatory changes in the US.
- A review of recent developments regarding international trade agreements.
Highlights
Pay-for-delay deals received renewed attention in the first half of 2011. While in Europe, such deals are on the decline, their use is on the rise in the US. Consequently, the US government is looking to ban pay-for-delay deals in order to prevent generic entry being delayed.
In the US, generic producers now face $299m in annual user fees, while more new bioequivalence guidelines have been put in place requiring greater levels of transparency – with such measures both benefitting and hindering the generics industry.
Regulatory authorities in the US, EU and Australia are beginning to work together to lessen the workload in processing good manufacturing practice (GMP) certification for pharmaceutical manufacturers, in a move which could result in significantly quicker GMP certification.
Table of Contents
5 EXECUTIVE SUMMARY
5 Strategic scoping and focus
6 Datamonitor key findings
9 GENERICS MARKET DYNAMICS
9 Generic uptake and market sizing
13 COST-CONTAINMENT STRATEGIES CONTINUE TO IMPACT GENERICS
13 Concern grows in Europe over the impact of reference pricing
15 Extension of the German AOK tendering system will generate further cost savings
17 INTRODUCTION OF INN PRESCRIBING WILL DRIVE GENERIC UPTAKE
18 India considers introducing INN prescribing
19 French insurers call for INN prescribing
19 Spain looks towards INN prescribing in desperate attempts to curb government expenditure
20 Australia and Spain dedicate funding to promoting public awareness of generics
20 An essential medicines list may boost generic uptake in Brazil
21 PAY-FOR-DELAY DEALS FACE GROWING REGULATORY SCRUTINY
21 The US experienced a significant rise in pay-for-delay cases in 2010
23 EU reduction in problematic patent settlements due to closer regulatory monitoring
25 REGULATORY CHANGES IN THE US ARE A MIXED BAG FOR GENERIC PRODUCERS
25 The FDA and generics industry reaches an agreement over generic user fees
25 US introduces additional bioequivalence requirements for ANDAs
26 Generics companies cannot be liable for drug labeling
26 FDA examines new tablet size requirements in order to help improve patient compliance
28 FREE TRADE AGREEMENTS WILL DRIVE THE GLOBAL TRADE OF GENERICS
28 Japan and India negotiate a regulatory exchange
29 EU-India Free Trade Agreement sparks international protests
30 EU and India reach a deal to end seizures en route to emerging markets
30 Trade agreements between Latin America and the EU run into difficulties
32 DEVELOPED COUNTRIES COOPERATE ON GMP
32 EMA, FDA, and TGA join forces on GMP
32 Russia to become a more difficult market for international generics producers to penetrate
33 BIBLIOGRAPHY
33 Publications and online articles
40 Datamonitor reports and products
41 APPENDIX
41 Exchange rates used in this report
LIST OF FIGURES
9 Figure 1: Comparison of generic volume uptake in the major pharmaceutical markets (%),
2009–10
10 Figure 2: Comparison of generic value uptake in the major pharmaceutical markets (%),
2009–10
11 Figure 3: Comparison of generics market size in the major pharmaceutical markets, 2009–10
21 Figure 4: Patent settlements in the US, 2008–10
LIST OF TABLES
9 Table 1: Generic penetration in major pharmaceutical markets, 2009–10
13 Table 2: Reference pricing practices across European markets, 2011
15 Table 3: Pricing and reimbursement cuts that have impacted generics producers, 2010–11
17 Table 4: Generic prescribing practices in major markets, 2011
23 Table 5: European Commission patent settlement investigations, 2008–11
28 Table 6: Trade agreements likely to impact generics producers, 2011
30 Table 7: Provisions under free trade negotiations and their impact on Mercosur countries
41 Table 8: Currency exchange rates, 2011
Figure 1: Comparison of generic volume uptake in the major pharmaceutical markets (%), 2009-10
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