Regulatory and development issues hurdles exist but are surmountable

Europe serves as a model for other countries looking to define their own regulatory approval criteria. The US is on the brink of passing legislation to establish a statutory pathway for biosimilars approval but the opposing interests of biosimilar and innovative companies may result in further delays. Development of biosimilars presents many challenges and potential pitfalls.

Europe has shown a degree of flexibility in its approval of 5 biosimilars to date. Although guidance has been issued biosimilar developers are urged to communicate with the EMEA as approval remains on a case-by case basis. Naming of biosimilars remains a contentious and unresolved issue as it carries implications for substitution with biosimilars.

The increasing expenditure on biologics is pressuring US lawmakers to formulate a statutory pathway for approval of biosimilars. The Biologics Price Competition and Innovation bill proposes a compromise attempting to satisfy both innovative and biosimilar companies. However its future is uncertain as it faces a slow progress in Congress.

Design of the biosimilar manufacturing process is key process knowledge and understanding of potential risks and pitfalls are necessary to minimize the time and cost of development. Selection of analytical methods for assessing biosimilars quality is critical as each method answers a different question about the product.

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