Biological and Biosimilar Medicinal Products

What is a biological medicinal product?

A biological medicinal product is a medicinal product that contains an active substance produced or excreted from biological sources (human, animal, or microbiological).

Due to manufacturing procedures and their origin, active substances of biological medicine shave significantly complex structure as compared to chemical active substances.

Some of the active substances of biological medicines may be found in human body, like insulin, growth hormone, or erythropoietin.

Biosimilars – Inflated Expectations?

In October 2006, Senators Waxman, Schumer and Clinton introduced the “Access to Life-Saving Medicines Act” to the US Congress in an attempt to establish an abbreviated application process for biological products.

It was the same Senator Waxman who cooperated in 1984 with Senator Hatch to introduce what became known as the Hatch-Waxman Act to introduce a simplified method of registration for generics.

Before that, there had been virtually no generics market in the USA due to the massive barriers to entry, which had made the process too difficult for cheap copies to enter the market. For example, all new products had to provide the FDA with full toxicology and efficacy data, even for molecules that were well established and well known.