Biosimilars in Emerging Markets
Biosimilars in Emerging Markets
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Follow-on biologics have been embraced enthusiastically in most emerging markets, where they promise to deliver much-needed improvements in access to a generation of products that remains beyond the reach of many patients.
Publisher: Datamonitor Healthcare
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Follow-on biologics have been embraced enthusiastically in most emerging markets, where they promise to deliver much-needed improvements in access to a generation of products that remains beyond the reach of many patients. They have been registered in substantial numbers, and have been prescribed and purchased widely, expanding treatment populations and eroding originator revenues. By the early part of this decade, follow-on biologics were generating annual sales of around $600m in China alone. With follow-on products winning key government tenders in countries like Mexico and Russia, and being purchased by a growing number of patients in self-pay markets such as India, aggregate sales of copy biologics in the six BRIC-MS (Brazil, Russia, India, China, Mexico, and South Korea) countries now almost certainly exceed $1.5bn.
Many follow-on biologics being sold in BRIC-MS countries were subject to cursory regulatory reviews, and would not meet biosimilarity standards required to obtain marketing authorization in highly regulated markets. Some have been tested more rigorously, however, and manufacturers based in South Korea and India have begun to emerge as major players on the global biosimilars stage. In the meantime, regulators in all six BRIC-MS countries have introduced new, more rigorous requirements for the approval of follow-on biologics. These will trigger a degree of restructuring in most emerging biosimilar markets, piquing the interest of international players. BRIC-MS policymakers are keen to encourage the development of local manufacturing capabilities in the biologics sector, however, and foreign companies attempting to service emerging markets via biosimilar imports will face challenging administrative, regulatory, and pricing barriers.
Throughout this report, the term “follow-on biologic” is used generically, referring to any non-originator biologic, whether “biosimilar” or not. Despite its title, the report includes information on products that could not be described accurately as “biosimilars,” a term reserved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for biological medicines that are “similar to another biological medicine already authorized for use.” To obtain an EMA or FDA marketing authorization, a biosimilar application must contain data showing that the product is “similar to the reference medicine” and that there are “no meaningful differences” between the two products in terms of quality, safety, or efficacy.
Early follow-on biologics commercialized in most BRIC-MS countries were subject to much less onerous requirements, and many would fail the EMA’s or FDA’s biosimilarity test. These are often described as “copy biologics.” Regulators in all six BRIC-MS markets have since implemented much tighter requirements governing the approval of follow-on products, however. While these refer variously to “biological products” (Brazil), “similar biologics” (India), or “biocomparables” (Mexico), all now require the production of substantive clinical data. In most cases this includes comparability data and, as such, it is reasonable to describe products approved under these new regulatory frameworks as biosimilars.
CONTENTS
7 EXECUTIVE SUMMARY
7 Low IP and regulatory barriers provided an early path to market
7 Original biologics have been hit hard in BRIC-MS markets
7 Tighter regulations have begun to affect BRIC-MS market dynamics
8 Governments remain firmly on the side of local manufacturers
8 Leading BRIC-MS players are spreading their wings
8 The long-term potential of BRIC-MS biosimilar markets is huge
10 THE BIOSIMILARS MARKET
10 Biologics are transforming drug therapy, but are heaping pressure on healthcare finances
11 Uncertainty and confusion delayed biosimilar approval and uptake in developed markets
13 Follow-on biologics forged ahead in emerging markets
13 Market dynamics handed Asian players a significant lead in the sector
18 Biosimilar drivers outweigh constraints in emerging markets
23 Bibliography
29 THE BIOSIMILARS LANDSCAPE IN EMERGING MARKETS
29 Diversity reflects unique national market dynamics
29 Early originator targets suffer badly
29 Insulins, etanercept, and a raft of MAbs are now in the firing line
30 Recent launches have triggered a sharp increase in BRIC-MS biosimilar market values
31 Local players have grabbed early leadership positions
32 Price erosion in some emerging markets may be less dramatic than anticipated
32 BRIC-MS biosimilar pipelines are richly stocked
35 MAbs dominate the list of most popular biosimilar targets
36 Local champions are now pursuing roles on the global biosimilars stage
42 Other BRIC-MS players will follow the “big three” into highly regulated markets
43 However, long-term prospects for many local players will be less rosy
43 Bibliography
48 BRAZIL
48 Lack of local expertise limits early activity
48 Foreign players step into the relative void
49 ANVISA moves early on regulatory guidance for follow-on biologics
50 Government pursues biologics import substitution drive
53 SUS procurement rules and PDPs complicate the biosimilar pricing environment
54 Foreign companies eye biosimilar MAb opportunities
57 Bibliography
61 RUSSIA
61 Follow-on products have transformed key market segments
63 A regulatory pathway for follow-on biologics is finally drawn up
64 Roche litigation failure spells bad news for original biologic patents
65 New rules establish ceiling prices for follow-on biologics
65 Import substitution and drug coverage aspirations to drive the market
66 Biosimilar trial activity has rocketed
68 Bibliography
71 INDIA
71 Steady flow of “similar biologic” approvals continues
73 New guidelines promise earlier access for follow-on biologics
74 Legal battles persist, even where patents are not an issue
75 Follow-on products drive prices down, but affordability remains a key issue
77 Market prospects remain positive
80 Bibliography
84 CHINA
84 Locals home in early on “easy” biologic targets
86 Regulators step up requirements for follow-on biologics
88 New regulatory requirements will trigger a local industry shake-out
90 Bibliography
94 MEXICO
94 Early follow-on products make significant inroads
95 Raising the regulatory bar for follow-on biologics
96 Probiomed loses patent spat with Roche over rituximab
97 MAbs feature prominently in the biocomparables pipeline
99 Changes in the competitive landscape are anticipated
100 Bibliography
103 SOUTH KOREA
103 Government support drives early investment in biosimilars
103 Pro-active approach bears global as well as local fruit
105 Domestic launches force Korean biologic prices down
105 With global markets in their sights, regulators set the biosimilars bar high
106 Remsima spearheads a biologics export boom
107 Launch activity is beginning to heat up
110 Bibliography
114 APPENDIX
114 About the author
114 Scope
114 Definitions
114 Methodology
LIST OF FIGURES
19 Figure 1: Contribution of cancer and diabetes to overall mortality in emerging markets
30 Figure 2: The second wave of follow-on biologics in BRIC-MS markets
31 Figure 3: Leading companies in India by volume of approved/launched follow-on biologics
34 Figure 4: Status of biosimilar clinical trials in the BRIC-MS markets
35 Figure 5: Biosimilar development by country and phase
36 Figure 6: Most popular biosimilar development targets in the BRIC-MS countries
55 Figure 7: Brazil: biosimilar competition in the pipeline, by volume per reference biologic
63 Figure 8: Russia: biosimilar companies by volume of approved or launched biosimilars
67 Figure 9: Russia: biosimilar competition in the pipeline, by volume per reference biologic
68 Figure 10: Russia: biosimilar companies by volume of biosimilars in preclinical through to Phase III development
71 Figure 11: Original biologics facing competition from more than one follow-on product in India
73 Figure 12: Companies with more than two approved/launched follow-on biologics in India
78 Figure 13: India: biosimilar competition in the pipeline, by volume per reference biologic
79 Figure 14: India: biosimilar companies by volume of biosimilars in preclinical through to Phase III development
98 Figure 15: Biosimilar MAbs in the Mexican development pipeline
108 Figure 16: Foreign company involvement in preclinical through to Phase III biosimilar development in South Korea
109 Figure 17: Five most popular targets of biosimilar development activity in South Korea
LIST OF TABLES
11 Table 1: Global sales of best-selling pharmaceutical brands, 2015
12 Table 2: Biosimilars and generics: key differences
15 Table 3: Major tie-ups between leading BRIC-MS biosimilar players and global/regional partners
21 Table 4: Regulating follow-on biologics/biosimilars in the BRIC–MS markets
33 Table 5: Biosimilar development activity in the BRIC-MS markets
37 Table 6: US, EU, and Japanese approvals of Biocon, Celltrion, and Samsung Bioepis biosimilars
38 Table 7: US, EU, and Japanese biosimilar filings by Biocon, Celltrion, and Samsung Bioepis
39 Table 8: Biocon’s biosimilars pipeline
41 Table 9: Celltrion’s biosimilars pipeline*
42 Table 10: Samsung Bioepis’s late-stage biosimilars pipeline
49 Table 11: Availability of four key follow-on biologics in Brazil
50 Table 12: Average time taken to authorize biological drugs in Brazil
53 Table 13: PDP contracts awarded for key biologics, 2015/2016
56 Table 14: Brazil: biosimilar companies by volume of biosimilars in preclinical through to Phase III development
62 Table 15: Follow-on MAb products approved in Russia
72 Table 16: First approval dates for MAb-based follow-on biologics in India
75 Table 17: Biologic price erosion following the arrival of follow-on products in India
85 Table 18: Impact of biosimilar competition in China’s tumor necrosis factor inhibitor market
89 Table 19: Shanghai Henlius Biotech’s biosimilar monoclonal antibody pipeline
94 Table 20: Follow-on filgrastims registered and commercialized in Mexico
104 Table 21: Key biosimilar approvals in South Korea, 2012–16
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