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Biosimilars in Emerging Markets

  • March 2017
  • Firstword Pharma
Report ID: 1183561



Biosimilars: Make the most of high risk emerging market opportunities

Emerging biosimilars markets are currently a $5billion opportunity with even more growth potential ahead. Lower drug costs and improved patient access are attractive to governments, insurers and patients too. But with market regulations that are full of loopholes, bias in market access and powerful national champions dominating the field, emerging markets are notoriously difficult to navigate. How can market entrants build a solid team and forge local alliances for success? And what is the single greatest threat to establishing a thriving, competitive emerging market trade in biosimilars?

Report Overview
With detailed country profiles plus insights from local industry executives with real-world experience in today’s most attractive emerging markets, Biosimilars in Emerging Markets: Navigating the Challenge offers practical recommendations and success strategies to help protect against the significant risks involved.

Report Features
- What you need to know about the patchwork of regulatory developments in key emerging markets: what the rules say, what data is essential and where the gaps are.
- In-depth analysis and country profiles for the 6 most attractive emerging markets (Brazil, Mexico, China, India, Russia and Turkey.
- Unique ‘commercial opportunity versus ease of access’ attractiveness ranking for 12 countries including emerging players such as Argentina, Nigeria and Saudi Arabia.
- All the hot-button issues such as biosimilar interchangeability, reference medicines, indication extrapolation and IP rights – and how you can turn them to your advantage.
- The current state of play regarding biosimilars market access in the countries attracting the most interest. Will your biosimilar face a price cap? How are drug tenders organised?
- Expert recommendations and strategies from industry leaders on how to prioritise and prepare, issues to avoid, tools and resources needed, and what to expect.

Key Benefits
- Avoid ‘analysis paralysis’: Get up to speed on the bigger picture and bring together expert views and principles so you can proceed with confidence.
- Understand the differences: Approaching multiple emerging markets with a ‘one-size-fits-all’ plan is dangerous. The issues may be similar but success strategies will differ. What is important in each country, and what activities are required to mitigate risk?
- Be prepared for the threats: Use expert insight to prepare ahead for the ‘make or break’ factors impacting new market entrants. What must you know before planning your approach?
- Know where to focus resources: Build the right team, make better decisions by assessing when and where problems are most likely to arise, and understand which markets best fit with your internal strengths.
- Build a targeted strategy: Use specific profiles to dig deeper into market drivers, obstacles, policy, regulatory and IP issues, market access and competitors.

Why the fuss about emerging markets?

It’s no secret that launching biosimilars into emerging markets is a growth opportunity, but this is one area where it really does pay to look before you leap. A clear cut, tried and tested route to success doesn’t exist and nobody likes uncertainty. So, are you prepared for a potentially bumpy ride? Have you timed your entrance well? Most importantly, do you have a plan to address the specific challenges you will undoubtedly encounter?

Key Questions Answered By This Report
- What barriers to acceptance do biosimilars face?
- Which emerging markets are moving with the times, and which are playing catch-up with global gold-standard regulations?
- What are the critical success factors and key steps for market entry and funding?
- How big is the gap between rules and practice?
- When are the best times to play on price or quality?
- How can quality biosimilars be differentiated from competitors?
- How will originators and local companies challenge new entrants?
- How can local partners boost market access and build strong payer relationships?
- What does the right team look like, and what skill sets are critical?

Expert Views
The experts interviewed for this report all have in-depth experience of biosimilars in today’s emerging markets. To enable them to express candid views, all were offered the option to remain anonymous.
- Director, international biosimilars company
- Director, international biosimilars company
- Manager, India-based generics manufacturer
- International regulatory affairs consultant
- Biosimilars Unit Director, Indian biotechnology company
- Commercial Strategy Director, India-based biotech
- Market Access Director, Brazilian biotech
- Dr. Xavier Tello, Regulatory Affairs Consultant, Mexico

3 Key Quotes
“IP is becoming an issue now in emerging markets. The multinationals are making all the ‘old hat arguments’ about extrapolation and switching from 10 years ago.” Biosimilars Unit Director, Indian biotechnology company

“The key trend in the next five years is that markets like Russia, China or India will have more clarity on biosimilars regulation. Secondly the role of local players will increase – we have seen this already in India and Russia, and we anticipate that in China too.” Director, international biosimilars company

“How will emerging-market companies evolve in terms of market size? For sure, the multinationals could set up production in a low-cost country, but local clout can make a difference and that is why we value local players [in our alliances].” Biosimilars Unit Director, Biotechnology company

Who Would Benefit from This Report?
- Biosimilar manufacturing companies
- Research libraries within multi-nationals
- Market access teams
- Intellectual property professionals
- Regulatory affairs departments for specific markets
- Government affairs professionals
- Brand marketing departments facing biosimilar competition
- Senior leadership teams looking at investment in emerging markets

Content Highlights
Executive summary
- Overview: biosimilars in the emerging world
- A small market with enormous potential
- Regulations in emerging markets are maturing, but are not harmonised
- Timeline of first publication of national or supra-national biosimilars guidelines
- Map of emerging biosimilars markets by level of regulatory development
- No consensus on classifying reference products or biosimilars naming

Approval steps in biosimilars registration
- Extrapolation of indications is still a concern for emerging markets
- Post-marketing surveillance exposes the gap between rules and practice
- Biosimilars in the age of economic chauvinism
- Product pipeline data show a thriving emerging-market industry
- Pipeline of biosimilar monoclonal antibodies in emerging markets
- Pipeline of non-monoclonal antibody biosimilars in emerging markets
- In market access, biosimilar players face different challenges to originators
- Funding & pricing attributes of leading emerging markets
- Time to market is a major challenge, even where abbreviated pathways are available
- Market access timelines for pharmaceuticals in emerging markets

Regional profiles
- Latin America
- Biosimilars Country Profile: Brazil
- Biosimilars drivers & resistors in Brazil
- Healthcare Policy
- Regulatory and intellectual property issues
- Market access
- Competitive Landscape
- Outlook
- Biosimilars Country Profile: Mexico
- Biosimilars drivers & resistors in Mexico
- Healthcare policy
- Regulatory and intellectual property issues
- Market access
- Competitive Landscape
- Outlook
- Regional profile: Asia
- Biosimilars Country Profile: China
- Biosimilars drivers & resistors in China
- Healthcare policy
- Regulatory and intellectual property issues
- Market access
- Competitive Landscape
- Outlook
- Biosimilars Country Profile: India
- Biosimilars drivers & resistors in India
- Healthcare Policy
- Regulatory and intellectual property issues
- Market access
- Competitive Landscape
- Outlook
- Other key emerging markets
- Biosimilars drivers & resistors in Russia
- Healthcare Policy
- Regulatory and intellectual property issues
- Market access
- Competitive Landscape
- Outlook
- Biosimilars drivers & resistors in Turkey
- Healthcare Policy
- Regulatory and intellectual property issues
- Market access
- Competitive Landscape
- Outlook

- Prioritising emerging biosimilars markets
- Opportunity vs. access in emerging biosimilar markets
- Critical success factors

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