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Biosimilars in Emerging Markets

  • ID: 4421367
  • Report
  • April 2017
  • Region: Global
  • 116 pages
  • Datamonitor Healthcare
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.
Note: Product cover images may vary from those shown
  • Low IP and regulatory barriers provided an early path to market
  • Original biologics have been hit hard in BRIC-MS markets
  • Tighter regulations have begun to affect BRIC-MS market dynamics
  • Governments remain firmly on the side of local manufacturers
  • Leading BRIC-MS players are spreading their wings
  • The long-term potential of BRIC-MS biosimilar markets is huge
  • Biologics are transforming drug therapy, but are heaping pressure on healthcare finances
  • Uncertainty and confusion delayed biosimilar approval and uptake in developed markets
  • Follow-on biologics forged ahead in emerging markets
  • Market dynamics handed Asian players a significant lead in the sector
  • Biosimilar drivers outweigh constraints in emerging markets
  • Bibliography
  • Diversity reflects unique national market dynamics
  • Early originator targets suffer badly
  • Insulins, etanercept, and a raft of MAbs are now in the firing line
  • Recent launches have triggered a sharp increase in BRIC-MS biosimilar market values
  • Local players have grabbed early leadership positions
  • Price erosion in some emerging markets may be less dramatic than anticipated
  • BRIC-MS biosimilar pipelines are richly stocked
  • MAbs dominate the list of most popular biosimilar targets
  • Local champions are now pursuing roles on the global biosimilars stage
  • Other BRIC-MS players will follow the “big three” into highly regulated markets
  • However, long-term prospects for many local players will be less rosy
  • Bibliography
  • Lack of local expertise limits early activity
  • Foreign players step into the relative void
  • ANVISA moves early on regulatory guidance for follow-on biologics
  • Government pursues biologics import substitution drive
  • SUS procurement rules and PDPs complicate the biosimilar pricing environment
  • Foreign companies eye biosimilar MAb opportunities
  • Bibliography
  • Follow-on products have transformed key market segments
  • A regulatory pathway for follow-on biologics is finally drawn up
  • Roche litigation failure spells bad news for original biologic patents
  • New rules establish ceiling prices for follow-on biologics
  • Import substitution and drug coverage aspirations to drive the market
  • Biosimilar trial activity has rocketed
  • Bibliography
  • Steady flow of “similar biologic” approvals continues
  • New guidelines promise earlier access for follow-on biologics
  • Legal battles persist, even where patents are not an issue
  • Follow-on products drive prices down, but affordability remains a key issue
  • Market prospects remain positive
  • Bibliography
  • Locals home in early on “easy” biologic targets
  • Regulators step up requirements for follow-on biologics
  • New regulatory requirements will trigger a local industry shake-out
  • Bibliography
  • Early follow-on products make significant inroads
  • Raising the regulatory bar for follow-on biologics
  • Probiomed loses patent spat with Roche over rituximab
  • MAbs feature prominently in the biocomparables pipeline
  • Changes in the competitive landscape are anticipated
  • Bibliography
  • Government support drives early investment in biosimilars
  • Pro-active approach bears global as well as local fruit
  • Domestic launches force Korean biologic prices down
  • With global markets in their sights, regulators set the biosimilars bar high
  • Remsima spearheads a biologics export boom
  • Launch activity is beginning to heat up
  • Bibliography
  • About the author
  • Scope
  • Definitions
  • Methodology
List of Figures
Figure 1: Contribution of cancer and diabetes to overall mortality in emerging markets
Figure 2: The second wave of follow-on biologics in BRIC-MS markets
Figure 3: Leading companies in India by volume of approved/launched follow-on biologics
Figure 4: Status of biosimilar clinical trials in the BRIC-MS markets
Figure 5: Biosimilar development by country and phase
Figure 6: Most popular biosimilar development targets in the BRIC-MS countries
Figure 7: Brazil: biosimilar competition in the pipeline, by volume per reference biologic
Figure 8: Russia: biosimilar companies by volume of approved or launched biosimilars
Figure 9: Russia: biosimilar competition in the pipeline, by volume per reference biologic
Figure 10: Russia: biosimilar companies by volume of biosimilars in preclinical through to Phase III development
Figure 11: Original biologics facing competition from more than one follow-on product in India
Figure 12: Companies with more than two approved/launched follow-on biologics in India
Figure 13: India: biosimilar competition in the pipeline, by volume per reference biologic
Figure 14: India: biosimilar companies by volume of biosimilars in preclinical through to Phase III development
Figure 15: Biosimilar MAbs in the Mexican development pipeline
Figure 16: Foreign company involvement in preclinical through to Phase III biosimilar development in South Korea
Figure 17: Five most popular targets of biosimilar development activity in South Korea

List of Tables
Table 1: Global sales of best-selling pharmaceutical brands, 2015
Table 2: Biosimilars and generics: key differences
Table 3: Major tie-ups between leading BRIC-MS biosimilar players and global/regional partners
Table 4: Regulating follow-on biologics/biosimilars in the BRIC-MS markets
Table 5: Biosimilar development activity in the BRIC-MS markets
Table 6: US, EU, and Japanese approvals of Biocon, Celltrion, and Samsung Bioepis biosimilars
Table 7: US, EU, and Japanese biosimilar filings by Biocon, Celltrion, and Samsung Bioepis
Table 8: Biocon's biosimilars pipeline
Table 9: Celltrion's biosimilars pipeline*
Table 10: Samsung Bioepis's late-stage biosimilars pipeline
Table 11: Availability of four key follow-on biologics in Brazil
Table 12: Average time taken to authorize biological drugs in Brazil
Table 13: PDP contracts awarded for key biologics, 2015/2016
Table 14: Brazil: biosimilar companies by volume of biosimilars in preclinical through to Phase III development
Table 15: Follow-on MAb products approved in Russia
Table 16: First approval dates for MAb-based follow-on biologics in India
Table 17: Biologic price erosion following the arrival of follow-on products in India
Table 18: Impact of biosimilar competition in China's tumor necrosis factor inhibitor market
Table 19: Shanghai Henlius Biotech's biosimilar monoclonal antibody pipeline
Table 20: Follow-on filgrastims registered and commercialized in Mexico
Table 21: Key biosimilar approvals in South Korea, 2012-16
Note: Product cover images may vary from those shown