Does biosimilar entry reduce cost for patients?

Biosimilars aim to be lower cost options for biologic therapies after loss of exclusivity. A key question is whether these cost savings get passed through to patients via lower out-of-pocket costs. A paper by Dayer et al. (2026) aims to answer this question using 2011-2023 Merative MarketScan Commercial claims data. The authors observed: …significant patient…

How many patients are switching to biosimilars?

That is a key question if long-run drug prices are going to come down for biologic products. We can decompose this question into 3 sub-questions: What share patients initiating therapy start on a biosimilar? What share of patients already using a biologic products switch to a biosimilar? Do patient of physician factors drive biosimilar prescribing…

Biosimilar Market Report

Samsung Bioepis has a Biosimilar Market Report for Q2 2024. Some key highlights: As of April 2024, the FDA has approved a total of 48 biosimilars across 15 unique biological molecules.  Of the 48 approvals, 38 biosimilars have launched in the US market.   In Q2 2024, 3 new biosimilars were approved in the US (Simlandi…

Biosimilars Role in Improving Patient Access

Today I was on Mark Hansan and Scott Howell’s podcast Prescription for Better Access Podcast on the topic “Biosimilars Role in Improving Patient Access“. The full episode with description is below or you can download the audio-only podcast here. Biosimilars are entering the market at their fastest pace ever. In this episode, we interview a…

Utilization management for biosimilars

When we think of utilization management (e.g., prior authorizations, step edits), we often think payers only use these for higher cost branded products including biologics. Generic drugs should have low cost sharing and limited utilization management. One question, however, is whether payers’ utilization management practices for biosimilars mirror those of biologic products, or small-molecule generics,…

Impact of 340B on the use of biosimilars

Biosimilar drugs for biologic treatments are analogous to generic drugs for branded small molecules. Switching to biosimilars after biologic patent expiry can save payers and patients money. Why doesn’t it happen more often? There are a variety of reasons but a paper by Bond et al. (2023) argues that the 340B program incentivizes hospitals to…

FDA’s 2022 Drug Approvals

The year 2022 was a good, but perhaps not great year for innovation. According to the FDA’s Center for Drug Evaluation and Research’s (CDER) New Drug Therapy Approvals 2022 report, there were 37 novel drugs approved in 2022. This number is down from the historical rate of approvals between 2013-2021 (43.4 approvals per year) and…

Barriers to biosimilar adoption

When typical drugs lose their period of exclusivity, new generic competitors arrive on the market with drastically lower prices. As patients switch from brand to generic drugs, the price of treatments declines. For biologic drugs, biosimilar uptake, however, is significantly less. In part, this is because biosimilars are difficult to manufacture so the price differences…