PHP23 - Biosimilar Market Access – Comparing the US and European Markets

Abstract

Interest in biosimilars has recently exploded with the advent of biosimilar monoclonal antibodies (mAbs), which represent an opportunity for significant payer savings. Biosimilars are a unique therapeutic class, typically following distinct regulatory and market access pathways. This research compares the differences in access, prescribing and dispensing for biosimilars mAbs between France, Germany, Italy, Spain, UK, and USA. Publically-available information on the access, prescribing and dispensing pathways for mAbs biosimilars were extracted and compared. The FDA and EMA have similar biosimilar approval pathways, requiring biosimilarity demonstration through PK/PD, immunogenicity and comparative clinical studies. For both, demonstrating biosimilarity in one indication allows approval for all indications of the reference product. The FDA can grant interchangeability status though no biosimilar mAb has achieved this to date. In Europe, interchangeability is determined by each country. In Italy, Spain and UK, biosimilars are not substitutable and no formal regulation exists in Germany. In France, laws allowing substitution in the retail settings have been passed but not yet enacted. All European countries in scope except Germany and UK conduct an HTA assessment of biosimilars as they would a reference biologic. In Germany, no HTA assessment is conducted, while NICE generally considers biosimilars in the context of a Multiple Technology Appraisal in parallel with their reference product. Unlike generics, there are no specific incentives in the USA, France or Spain to encourage biosimilar prescriptions whilst Italy and Germany have physician quotas. UK has therapeutic guidance recommending biosimilars but no enforceable laws. The access environment for biosimilars in the USA appears to be currently less favourable than some other European markets, most notably Germany. This is driven by a lack of incentives to prescribe or substitute biosimilars. However, the prospect of a nation-wide interchangeability status granted by the FDA could make this significantly more favorable.