June 15, 2012 (Vol. 32, No. 12)

Actual Performance Varies between Regulated and Semi- and Unregulated Environments

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.

Valuation of Global Demand for Biosimilars

Market Growth

A recent report by BCC estimates that global demand is expected to grow at a CAGR of approximately 8% between 2012 and 2016. The product categories excluded by the EMA and those for which biosimilar approval guidelines are not being developed by the agency are excluded from this estimation and forecast.

Low-molecular weight heparin (LMWH) biosimilars accounted for 44% of the global biosimilar market in 2011. Even though these are not recombinant therapeutic products, the EMA has developed biosimilar guidelines for this class of products due to their high complexity. Hence, these products are within the scope of the study. Other product classes with significant market shares included biosimilars of erythropoietin, growth hormones, and filgrastim.

Partnerships and investments are driving the sector worldwide. Countries in the Asia Pacific region are particularly active in the development and commercialization of biosimilars in the semi- and unregulated markets.

Under favorable regulatory conditions, and assuming most of the safety and efficacy concerns will be answered favorably, the market demand for biosimilars may witness a significant increase after the forecast period of this study as many of the current blockbuster biologic drugs will face patent expiry between 2013 and 2020 in the developed markets.

During the forecast period of this report, the effect of some of the blockbuster biologic drugs losing patent protection is expected to be limited. This is due to the potential time gap between the patent expiry of an innovator biologic brand and the acceptance of its biosimilar brand by the market. Besides, many blockbuster biologic drugs are coming off patent protection soon after the forecast period.

Even though the biosimilar pipeline looks promising, the number of high-value products such as monoclonal antibodies in advanced stages of development are limited. Beyond 2016, it can be expected that the market may be better equipped to accept new biosimilars of several categories of recombinant therapeutic products based on the safety and efficacy demonstrated by the already approved biosimilars. This may impact the biosimilar market growth beyond 2016. The table presents a list of some of the biosimilar products in development worldwide.

The global demand for monoclonal antibody biosimilars is expected to grow at a CAGR of 17% between 2012 and 2016. The market demand for these products is expected to grow at an even higher rate beyond 2016 based on the development status of the pipeline biosimilar mAbs as well as the patent expiry and market acceptance trends.

Biosimilar Products in Advanced Stages of Development

Syamala Ariyanchira, Ph.D. ([email protected]), is the author of the upcoming report by BCC titled “Biosimilars: Global Markets”. She is an independent consultant based in Malaysia.

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