Biologic (Biological Product)

A biologic is a drug made from, or with the help of, living organisms. Traditional pills such as aspirin are small molecules built through chemistry. Biologics are usually large, complex molecules such as proteins and antibodies. The FDA says biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

Many of today's best-selling drugs are biologics, including injectable antibodies used for eczema, psoriasis, rheumatoid arthritis, Crohn's disease, and cancer. Because they target specific parts of the immune system, they can work where older drugs failed. They can also carry side effects that do not show up until large numbers of patients have used them for years.

Biologics are licensed through a Biologics License Application under the Public Health Service Act, a different pathway from the new drug application used for most chemical drugs. Cheaper follow-on versions are called biosimilars rather than generics. For litigation purposes, this matters less than people think: a biologic's maker has the same basic duty to warn about known risks as any drug company, and failure to warn is the core theory in most drug injury cases.

A current example is litigation over Dupixent, an antibody drug for eczema and asthma, where claims allege a link to a type of T-cell lymphoma. Those claims are allegations, not findings. If you used a biologic and were later diagnosed with a serious condition, keep your injection records and specialty pharmacy history.