Biosimilars in Emerging Markets: Opportunities, Challenges and Critical Success Factors

The biosimilars industry is increasingly focusing its attention on emerging markets, a move that offers both enormous potential and challenges. FirstView’s Biosimilars in Emerging Markets: Opportunities, Challenges and Critical Success Factors report offers timely insight into the right strategies and approaches for success.

Biosimilars in Emerging Markets: Opportunities, Challenges and Critical Success Factors pulls back the curtain on emerging markets to reveal the greatest challenges and opportunities for biosimilars. From critical components to success to which emerging markets are the most important for growth, get the information you need so your company can differentiate itself in this highly competitive market.

Gain specific insights on key emerging markets in Brazil, China, India, Mexico, Poland, Russia and Turkey. Learn which stakeholders hold the power as well as critical success factors.

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• Gain a competitive advantage with exclusive insights of 10 subject experts into the state-of-play for biosimilars in major emerging markets, set against the evolving biosimilars markets in developed countries
• Examine analysis of recent developments in the biosimilars market to understand how they will impact the sector and help frame your strategic approach
• Anticipate the business environment in seven major emerging markets using key data and experts’ views on important matters such as regulation, manufacturing and access to medicine
• Identify and activate critical success factors needed to win in the key biosimilar emerging market sectors

• Precise and timely analysis of emerging market trends and challenges for biosimilars
• Overview of offensive and defensive strategies employed by biotech companies
• Examination of the key drivers and resistors to biosimilars in emerging markets, with particular attention to the regulatory environment, protectionism and product quality
• Biosimilars development areas that present the best opportunities to meet a huge variety of stakeholder needs

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• Which biosimilars emerging markets are the most critical for the pharmaceutical industry?
• How do recent developments in the global biosimilars sector affect the future of biosimilars in emerging markets?
• What is the status of clinical trial activity in emerging markets for key classes such as monoclonal antibodies, insulin, erythropoietin-alfa (EPO-alfa), filgrastim and growth factors?
• What are the key strategies for success when it comes to manufacturing, clinical capabilities and partnering with local firms?
• How fragmented is the biosimilars market?

• CEO, European biosimilars developer
• CEO, Canadian biotechnology company
• CEO, Brazilian biotechnology company
• Senior Director, Accord Healthcare (formerly of Actavis and Teva)​
• R&D Director, Russian biotechnology company
• Global Biosimilars CI Manager, European biosimilars developer
• Global Biosimilars CI Manager, European originator biotechnology company
• Director of Biosimilars, Indian biotechnology company​
• Senior Manager, European biosimilars developer
• Globally focused biosimilars expert based in Europe

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“For the emerging markets, I think the number one success factor is to have a very good local partner. We really count on that as a key thing.”
Don Stewart, CEO, PlantForm.

“I think there is a need for more biologics in emerging markets that can treat Western style diseases. Drugs like mAbs to treat cancer and rheumatoid arthritis, insulin to treat diabetes and interferon-beta to treat MS, are now needed more than ever. Access to these products in emerging markets is low, and biosimilars have the potential to be able to improve access.”
Carsten Brockmeyer, CEO of Formycon

“My prediction is that formal biosimilar guidelines will be in place in the Russian market within the next 12 18 months. My company [Biocad] is leading an industry group which has developed a set of biosimilar guidelines. These guidelines have similar requirements to the EMA and WHO guidelines, and have been submitted to the Russian Ministry of Health for review.”
Roman Ivanov, VP R&D, CJSC Biocad

“A quality product is completely essential. You need a robust data package, a high quality drug master file. That is the key to success in Brazil, and many other emerging markets.”
Eduardo Cruz; CEO, Axis Biotec.