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…

Biosimilar use in France

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…

Biden’s Executive Order on Promoting Competition in the American Economy: What does it say about health care?

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…

First biosimilar hits the market

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…

Quotation of the Day: Pricing of Biosimilars

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…