Implications of non-distinguishable biosimilar names2018-05-09T08:55:56+00:00

Implications of non-distinguishable biosimilar names

“A manufacturer was interested in exploring the policy and reimbursement implications of proposed FDA policies regarding the non-proprietary naming of biosimilar products.”

Challenge

Over the past several years, the FDA has approved the first biosimilar treatments as lower-cost alternatives to biologic (large-molecule) therapies. In contrast to generic formulations of small-molecule treatments, biosimilars are not necessarily structurally identical to their reference products, due to the complexity of biologics and their manufacturing processes. A manufacturer was interested in exploring the policy and reimbursement implications of proposed Food and Drug Administration (FDA) policies regarding the non-proprietary naming of biosimilar products. In particular, the manufacturer was interested in the potential market impacts of these naming policies and their implications for pharmacovigilance.

Response

Develop a framework for understanding the positive and negative implications of product traceability policies on the quality and entry of biosimilar drugs into the marketplace. Raise awareness of the potential implications of non-distinguishable biosimilar names for drug safety and physician confidence.

Results

PHE developed an economic model to describe how product traceability may influence manufacturer investments in product quality and decisions to produce biosimilar products. PHE’s economic analysis found that policies which promote manufacturer accountability for serious safety problems, such as a distinguishable names policy, may promote the investment in quality and the entry of high quality products into the market. PHE also distilled key policy considerations into a commentary article targeted to policymakers and clinicians who may be interested in expanding access to biologic therapies.

Impact

PHE’s commentary on the implications of biosimilar launches for drug marketplace competition was published in the Journal of the American Medical Association (JAMA). This commentary article provided insights to policymakers on the role that distinguishable product names can play to support a robust market for biosimilars. PHE’s recommended policy of distinguishable non-proprietary names was eventually adopted by the US FDA. PHE also published its more detailed theoretical economic framework in the International Journal of Health Economics and Management, which provides technical arguments aligned with the recommendations made in the JAMA commentary article.

PHE’s commentary was published in the Journal of the American Medical Association.

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

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