Global Biosimilar Strategic Opportunity Assessment

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Project ThumbGlobal Biosimilar Strategic Opportunity Assessment
Top 10 Generic Drug Manufacturer

Our client needed to evaluate a number of strategic options regarding possible entry into the biosimilar category. VOI performed a thorough analysis of clinical, manufacturing, intellectual property and marketing issues in both advanced (e.g. US, EU, Canada) and emerging (e.g. India, China, Latin America) markets. The developing legislative and regulatory frameworks in these markets were explored in-depth. In countries such as the U.S., where governing regulations are in flux, the implications of various scenarios (e.g. different lengths of data exclusivity, clinical trial requirements) were explored.

Based on current market activity and probability-based (Monte Carlo) forecasts of future activity, we evaluated the commercial opportunity for the category as a whole and for selected biosimilar products. Factors considered in this phase included pricing / reimbursement, demand and penetration rates. Analyses of competitive actions, capital requirements, timing and potential partnership opportunities were also conducted. The final product included a net present value forecast of the biosimilar opportunity.


The results of our analysis were used as the basis for recommendations on both market entry and a “make or buy” path forward.


Drug development, biosimilars, regulations, biosimilar approvals, commercialization.

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