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Providing a Pathway for Biosimilars

By Patti Seymour and Howard Levine

While recent efforts to repeal the Patient Protection and Affordable Care and Biologics Price Competition and Innovation acts were unsuccessful, there remains a long road before biosimilars are a reality in the US. During a recent public hearing, FDA sought input on such controversial issues as exclusivity period, non-US reference product use, and proprietary drug names for biosimilars. Since then, the debate over exclusivity has intensified with a bipartisan Senate group urging FDA commissioner Margaret Hamburg to allow FDA to begin reviewing biosimilar applications four years after the reference product’s approval rather than waiting for the end of the 12 year exclusivity period. Waiting until the end of the 12 year period before initiating biosimilar product review would effectively extend exclusivity well beyond 12 years. President Obama’s 2012 budget proposes to shorten exclusivity to 7 years (potentially saving $2.3 billion over 10 years), but Commissioner Hamburg said in an interview that the agency is not focusing on this proposal because it would require Congress to change existing law.

Since most biologic products today are sourced from a single location but sold globally, allowing data generated from non-US approved reference standard in support of a biosimilar application is the right thing for FDA to do. Such a move would potentially reduce or eliminate the need for additional animal and human clinical studies, resulting in lower development costs which could be passed along to patients and payers in terms of lower prices.

At the same time, FDA must ensure proper pharmacovigilance for biosimilars as for innovator products. In the EU, even though a biosimilar product may be licensed for the same indications as an innovator product, the products are generally not readily substituted and doctors must specify which product is to be dispensed. We believe this is prudent until sufficient pharmacovigilance data is collected to ensure equivalent safety of the innovator and biosimilar products, even if this limits the full impact of biosimilars on healthcare costs. We agree with the EU position that the INN and company brand name must always appear together on a biosimilar label to reduce risk of substitution and enable proper pharmacovigilance and encourage FDA to follow suit. While some biosimilar developers have proposed using the NDC code to trace products, this approach is unlikely to ensure proper pharmacovigilance since product packaging containing this information may not always be retained after dispensing the product.

As expected, the industry is divided over these issues as constituencies lobby to protect their interests. While it is unlikely that a shorter overall exclusivity period will be approved, we support allowing biosimilar applications to be accepted and the review process to begin four years after an innovator product has been approved. The debate on substitutability will surely escalate as biosimilar developers lobby that their products are equivalent to the innovator’s. We shouldn’t have to wait long to learn how FDA plans to proceed since Commissioner Hamburg indicates FDA will unveil their guidelines “very soon.”