DUBLIN--(BUSINESS WIRE)--The "Biosimilars in Emerging Markets" report has been added to Research and Markets' offering.
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.
Key Topics Covered:
1 EXECUTIVE SUMMARY
- 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
2 THE BIOSIMILARS MARKET
- 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
3 THE BIOSIMILARS LANDSCAPE IN EMERGING MARKETS
- 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
4 BRAZIL
- 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
5 RUSSIA
- 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
6 INDIA
- 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
7 CHINA
- 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
8 MEXICO
- 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
9 SOUTH KOREA
- 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
10 APPENDIX
For more information about this report visit https://www.researchandmarkets.com/research/ql55lb/biosimilars_in
