Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment

Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment

The global market for biosimilars is valued at $243.8m in 2009 and is expected to increase to $4,697m in 2016 at a compound annual growth rate (CAGR) of 52.6%. The market will be driven by increasing pressure on governments to control rising healthcare expenditures and establishment of abbreviated regulatory approval pathway for biosimilars in the US besides patent expiry for major biologic drugs. The market is expected to gather momentum after the launch of biosimilar monoclonal antibodies.

GBI Research analysis finds that reduction of healthcare expenditures is on top of the agenda for governments and so initiatives on introducing regulations governing biosimilars seems to be of prime importance in developing nations. Since biologics are among the highest priced therapies in the world, controlling expenses due to high priced biologics is one of the key focus points and it has increased the expectations of a regulatory pathway among the biosimilars industry participants.

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Biologics Price Competition and Innovation Act (BPCIA), signed into law by US President Barack Obama in March 2010, establishes a regulatory pathway for approval of biosimilars in the US. The act empowers the FDA to develop standards to evaluate and approve biosimilars in the US. The act also grants FDA the authority to develop comprehensive guidelines for approval of biosimilar products or product classes. The act grants a market exclusivity of 12 years and data exclusivity of four years to innovator biologic drugs. Market exclusivity of 12 years is considered to be favorable to the innovator biologics.

GBI Research's analysis suggests that the high costs of development and manufacturing favors the success of large pharmaceutical companies with technical expertise, sales force strength and financial strength. Consequently, smaller players are not able to compete on financial grounds as well as production capacity. The biosimilars market is unlike the market for chemical drugs' generics counterpart where the development and manufacturing costs are comparatively much lower. The expected price reduction for a biosimilar is not more than 10% to 30% than that of the original biological. This marked difference between the biosimilars and traditional generic drugs, where the price reduction is more than 70%, is because biosimilars, unlike traditional generic drugs, require preclinical studies and clinical studies to prove bioequivalence and safety.

The cost of constructing a biopharmaceutical manufacturing facility is nearly $40m to $300m and the manufacturing process is very complex and needs technical personnel with expertise in biopharmaceutical manufacturing. Sales and marketing of biopharmaceutical drugs also needs experienced sales force, which the smaller biosimilars companies lack. While companies with financial muscle can afford these high costs and spend an average development time of six to eight years, smaller manufacturers are discouraged from entering the biosimilars market.

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