Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Summary of 2014 FDA Approvals

Small Molecules versus Biologics

Below is a summary of the 2014 FDA Approvals with respect to their classification as small molecule or biologic. Data is taken from the FDA website https://www.centerwatch.com/drug-information/fda-approved-drugs/year/2014

In molecular biology and pharmacology, a small molecule is a low molecular weight (<900 daltons) organic compound that may help regulate a biological process, with a size on the order of 10−9 m. Most drugs are small molecules.

From the FDA Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include:
• vaccines
• blood and blood products for transfusion and/or manufacturing into other products
• allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
• human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
• gene therapies
• cellular therapies
• tests to screen potential blood donors for infectious agents such as HIV

CONCLUSIONS:

As shown there were 106 small molecules approved and 59 biologics approved in 2014.

• Sales figures were or their anticipated market size as well as cost/benefit analysis.   This was mentioned as a very important requirement in drug development by JNJ. The pharmacy benefit managers, insurers and the pharma companies said they were talked early in the drug development process using cost/benefit analysis as a criteria of go/ no go decision point.
• The insurers are very cost conscious as well as the PBMs. There are some classes that had mainly biologics and this was not oncology. In addition inflammation had lots more small molecule. The breakdown seems to be more meaningful than the totals and there are many reformulations and double indications.