Mr McMaster stated that healthcare reform seemed to be the topic of the year for 2009, and wrapped up in the legislation is an approval process for biosimilars with balanced intellectual property protection for innovator biologicals. He asked how Dr Sherwin expects it to affect the industry in 2010.

Dr Sherwin: “Establishing a regulatory framework for biosimilars can increase patients' access to innovative therapies. However, we must be careful to preserve the intellectual property protections that support continued innovation. The incentive to invest in developing a novel biological therapy, diagnostic or vaccine is removed if the novel therapy cannot recoup the substantial research and development capital invested. The regulatory pathway for biosimilars should be established on equal footing to the Hatch-Waxman pathway for approving generic pharmaceuticals. Under the existing system, the average pharmaceutical does not face competition until 12 to 14 years after approval. A period of 12 to 14 years of data exclusivity for first-to-market biologicals would provide parity with the effective market protection of the US system for generic pharmaceuticals and with the EU’s established system for biosimilars, which provides 10 to 11 years of data exclusivity. The adoption of a regulatory pathway for biosimilars will allow more companies to deliver needed therapies to patients, hopefully bringing new efficiencies to the process and lowering costs. Done right, the approval process will also encourage continued innovation of future therapies.”

Reference:

Ashley McMaster. Looking Ahead to the New Year. An interview with Ceregene co-founder/Chairman and BIO Board Chair Dr Stephen Sherwin. BIO SmartBrief. 2009 December 15.