Though still in its infancy stages, biosimilars represent one of the most debated segments within the healthcare industry. The need for affordable healthcare combined with the number of innovator biologic drugs coming off patent offers huge opportunities for these products. Challenges for the stakeholders are equally huge, since scientific and regulatory uncertainties related to these products limit their growth potential.
While market uncertainties make investment decisions difficult, end-users—physicians as well as patients—have even more difficult decisions where they have to balance issues related to the safety, efficacy, availability, and potential consequences of switching from originator brands to biosimilar brands.
Market sentiments toward biosimilars vary widely between the regulated and the semi- and unregulated markets. While regulated markets adopt an extremely cautious approach, the “pharmerging” markets are embracing the opportunity—driven by rising healthcare costs as more and more branded biologics enter the market.
The fact that some of these countries do not have a stringent regulatory framework has helped local players enter the market with less of an investment. Though none of the biosimilar products from semi-regulated markets have received market authorization in regulated markets yet, many companies from emerging markets hope to enter the regulated markets using various strategies. In the process, these countries will become the testing grounds for local biosimilar companies looking to generate invaluable safety and efficacy information.
The term “biosimilar”, which was coined by the EMA, applies to biologic drugs approved by the agency as similar to the innovator biologic brands marketed in Europe. The stringent EMA regulatory framework establishes the similarity of these products with respect to the originator reference products.
The scope of the term as it is used in this article also includes products developed by companies in semi-regulated as well as unregulated markets, even though the quality of these products are often uncertain as they are not subjected to regulatory review comparable to that of the EMA.
Global market size of the biosimilar industry was around $2.5 billion in 2011. This estimation includes market demand for various categories of biopharmaceuticals included by the EMA in its definition of biosimilars and for which the agency has developed (or plans to develop) regulatory guidelines.