The Market for Biosimilars: Evolution and Policy Options

Abstract

• Biopharmaceuticals are more complex agents than conventional chemical entities and therefore are more difficult to replicate on patent expiry. Off-patent versions of the originator product cannot rely on a simple demonstration of chemical comparability. They are best described as biosimilar.

• As a consequence biosimilar markets will evolve in a more complex way than traditional small molecule chemical generics markets.

• Regulators will need clinical trial evidence prelaunch of efficacy and safety, and clinicians will require post-launch “patient safety year” (PSY) evidence that biosimilars are in practice equivalent in effect and safety to originators.

• As a consequence generic companies may need commercial partners to enter biosimilar markets successfully and governments and other payers need to behave differently. Post patent expiry price cuts and/or the use of reference pricing will deter biosimilar entry and reduce long term savings.

• Governments and other payers should encourage pharmacovigilance and other outcomes studies that produce PSY data that will encourage interchangeability and greater price competition. Over time these markets can become biogeneric.

• Outcomes data will also help assess the value for money of second generation biopharmaceutical products as compared to the first generation originator and biosimilar products.