Unbiased Analysis of Today's Healthcare Issues
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…
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…
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,…
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…
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…
That is the question I answer with my co-authors Ervant J. Maksabedian Hernandez, Marlon Graf, and Alexandria Portelli. The key finding is that at the molecule level, prices fall by only 18.6%, but this masks significant heterogeneity as the uptake of biosimilars varied dramatically across therapeutic class. The results from the paper’s abstract is below.…
I previously covered research from Dickson and Kent (2021) that examined how the entry of generic drugs impacts the price Medicare pays. In that study, the authors found that “the presence of 1 generic competitor was associated with a 14.9% mean price reduction in the bundled ASP, 2 generic competitors were associated with a 32.7%…
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…
Like generic drugs for small molecules, biosimilars offer the hope for reducing drug prices after biologic therapies lose their patent protections. But how big an impact do biosimilars have and how comfortable are physicians with using these substitute products? A paper by Robinson and Jarrion (2021) use data from France as a case study to…
Last Friday, President Biden released an executive order titled “Promoting Competition in the American Economy” While the order talk about transportation, internet companies, and farming, there were a number of provisions related to health care. I summarize each of these below. Specifically I review OTC hearing aids. Currently, many patients need to visit a doctor…