Picture of Biosimilars in Emerging Markets (2018)

Biosimilars in Emerging Markets (2018)

September 2018


Biosimilars: Evaluating opportunities and risks in emerging markets

Are you seeking new opportunities for biosimilars? The potential in emerging markets remains attractive, however the high-profile BRIC countries - and those further afield - are in a constant state of flux. Navigating your way through is risky and current information is key. What is the state of play today for pharma professionals seeking lucrative opportunities for new biosimilar drugs? What specific obstacles and strategies must biosimilar market entrants be aware of? And what stage in the evolutionary process have individual emerging markets now reached?

During June and July 2018, FirstWord interviewed 10 experts working for biosimilar companies in various emerging markets including Malaysia, Mexico, India, Korea, South Africa, Colombia, Thailand and the Middle East. We asked about trends, challenges and opportunities for biosimilars and explored the key issues including:

  • Identifying a confident approach: What level of biologic regulatory assessment should you expect? Is the full might of market access capability required when launching a biosimilar into an emerging market? How should you configure medical affairs, market access, sales and manufacturing?
  • The local versus global dilemma: What are the success factors required to deliver the most effective local presence? How should international capabilities be leveraged? What do you need to know to get the balance right?
  • Narrowing down: What is the latest thinking on the best opportunities for biosimilars? Which therapy areas and product niches inside and outside of BRIC are attractive, and why?
  • Keeping it real: Just how big are the opportunities for biosimilars in emerging markets? How do you measure their potential? And how do you avoid over-promising and under-delivering on commercial goals?
  • Moving beyond first base: What strategies should you consider to firm-up your market presence? Are local partnerships the right option both in the short- and long-term? Which messages resonate the most with payers and prescribers?

What to expect from this report

Moving beyond first base: What strategies should you consider to firm-up your market presence? Are local partnerships the right option both in the short- and long-term? Which messages resonate the most with payers and prescribers?

Use Biosimilars in Emerging Markets (2018) to learn from the experience of others and build your approach from a position of confidence.

How did we do it?

  • We identified the 7 current issues most pertinent to biosimilars in emerging markets
  • We explored these via an average of 29 targeted questions to each expert
  • Their responses provided 26 unique new insights
  • Insights are supported by 117 directly quoted comments plus an additional 24 sources

Example insight included in Biosimilars in Emerging Markets (2018)

"Alignment with Western regulatory standards is becoming the norm, but challenges exist. European Medicines Agency (EMA) standards are used in several emerging markets, but this is far from uniform. As such, variations in regulatory requirements from one emerging market to the next create inefficiencies and in some cases slow down product approval. In order to address this, some companies are keen to get involved in shaping the guidelines in certain countries so that the process works efficiently, and quality is maintained. The key message, however, is that some countries are still suffering from lack of agreement on what regulatory standards to adopt, particularly in relation to how countries regulate older products that were not developed to current regulatory standards."

Example quote included in Biosimilars in Emerging Markets (2018)

"Simply thinking about biotechnological products implies the development of a separate and specialised marketing structure. A 'small-molecule generic business model' will not work if you plan on expanding into biosimilars. You need to hire specialist people to communicate the value of the biosimilar to payers and prescribers."


"Our company is headquartered in Argentina, but each of the local subsidiaries (Chile, Uruguay, Peru, Paraguay, Colombia and Bolivia) have absolute autonomy to manage their own portfolio of products. In the case of licensed products, which are usually branded products, there is a regional structure that's responsible for ensuring alignment with standards at headquarters. This regional function has experts in health systems and they should know very well how to operate in each country, since all health systems are different. So they must adapt the campaigns, materials, messages and marketing methods to each country."

The expert panel for Biosimilars in Emerging Markets (2018)

  • Business Development Manager; South Africa-based pharmaceutical company
  • Carlos Dominguez; Commercial Director, Probiomed
  • CEO; North-America based biotech
  • Chief Commercial Officer; Thailand-based biotech
  • General Manager; Malaysian biosimilars company
  • Global Commercial Lead; India-based biosimilars manufacturer
  • Global Alliances Manager; East Asia-based biosimilars company
  • Government Affairs Director; Top 5 global pharmaceutical company, South Africa
  • Senior Manager, Emerging Markets; Top 5 global pharmaceutical company
  • Speciality Products Manager; Argentinean manufacturer