From The Stage

The Difference Between Pharmacokinetics and Pharmacodynamics

Dr. Chad Briscoe
Posted by Dr. Chad Briscoe / / Pharmacokinetics

In the United States, the safety and efficacy of prescription and over-the-counter drugs are a top priority for our government, medical professionals, and pharmaceutical companies. The Food and Drug Administration (FDA) is responsible for protecting public health by ensuring that any and all available medications are safe for human consumption, especially with regard to approving new medications or deciding whether or not a drug should be taken off the market. That even includes veterinary drugs and biological products as well. The cost of creating and testing a single drug can…

Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation

Krystal J. Alligood
Posted by Krystal J. Alligood / / Biosimilars, Industry Update, Pharmacokinetics

According to research from the Biosimilars Council, $81 billion worth of brand name biologics will lose their patents by 2020. As a result, we are seeing a significant increase in the development of lower cost biosimilar alternatives, as well as more applications for FDA approval of biosimilars for expiring biologic drugs. In fact, this market is expected to grow more than 25-fold over the next five years. But because the structure of a biosimilar is unlikely to be identical to that of the reference product, developers must ensure there are…