Biosimilars and Innovative Biological Drugs

Biological drugs are a paradigm in pharmacological innovation, as they can change the course of an illness by acting on a very specific aspect or mechanism of a cell, organ or system.

Anticuerpo monoclonal

Some of these drugs work very much like proteins the body produces, so when given to patients they can reduce the symptoms of an illness and halt or delay its progress.

Given their intrinsic characteristics (large molecules of proteins produced by living beings), the biological drug production process is complex and creates products with characteristics and properties that are closely tied to this process. This means that analyzing, characterizing and producing these drugs is more complicated than for chemically synthesized medicines and that, unlike the latter, biological drugs can not be copied exactly.

A biosimilar is a biological drug that is similar to another one that has already been authorized (reference biological drug) and has an expired patent. As it is a biological drug, a biosimilar is not exactly the same as the reference product because it is not an exact replica, unlike generic medicines and original chemical drugs.

So, getting biosimilar drugs approved takes more results from preclinical and clinical trials. The Spanish legal framework has made it obligatory to identify biological drugs by their trade name, and the law does not allow one biological drug to be given in place of another without the express authorization of the prescribing physician. Nevertheless, some aspects of current law do not recognize the difference between chemically synthesized and biological drugs.
This is particularly apparent in the Spanish reference pricing system, which treats a generic drug (developed in 2 to 3 years with an average investment of €3 million) the same way as it does a biosimilar (which costs between €100 million and €300 million and takes between five and eight years to develop).

Because of all this, at AseBio we recommend:

  • Patient information protocols should be put in place for biological drugs, which should have an impact on the overall quality of healthcare.
  • As it is inevitable that more and more biosimilars will reach the market, regulatory bodies and medical associations should develop policies to provide information and training on the regulations governing these drugs and the science behind them.
  • The introduction of biosimilars should not lead to practices that discourage the use of innovative molecules.