Unbiased Analysis of Today's Healthcare Issues
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…
How important is a name? In the case of biologics and biosimilars, billions of dollars depends on whether biosimilars can share the same name as branded biologics. WonkBlog explains the biologic vs. biosimilar debate: Biologics, which treat serious diseases like cancer and multiple sclerosis, are usually more expensive than conventional drugs, and they’re also harder to…
Making a generic version of a single molecule drug is fairly straightforward. Making a replica of a biologic treatment, however, is not. Nevertheless, Congress signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) to create a fast-track approval process for biological products that are demonstrated to be highly similar an FDA-approved biological product. These products…
Bilsimilars are biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. Biologic drugs can be patented, but once the patents expire, biosimilars can enter the market. Are biosimilars> priced similarly to generics? According to Ana…