What is the Difference Between Biosimilars and Biologics

The main difference between biosimilars and biologics is that biosimilars are biologics highly similar to an FDA-approved biological product, known as a reference product, whereas biologics are the medicine made from living cells. Furthermore, biosimilars are similar in terms of safety and effectiveness to the reference product while biologics are used to treat various diseases including cancer, chronic kidney disease, infectious diseases, autoimmune diseases, etc.

Biosimilars and biologics are two types of biological products of drugs, which are an effective method of controlling drug costs. Both are complex molecules like proteins synthesized inside living cells.

Key Areas Covered

1. What are Biosimilars
     – Definition, Features, Manufacturing
2. What are Biologics
     – Definition, Features, Manufacturing
3. What are the Similarities Between Biosimilars and Biologics
     – Outline of Common Features
4. What is the Difference Between Biosimilars and Biologics
     – Comparison of Key Differences

Key Terms

Biologics, Biosimilars, Food and Drug Administration (FDA), Generic Drugs, Living Systems

What are Biosimilars

Biosimilars are biological drugs or biologics that are similar to the FDA-approved biologic product known as the reference product. Though biosimilars have no meaningful differences in clinical terms of safety and effectiveness, some clinically-inactive components may occur in biosimilars.

Figure 1: Manufacturing Biosimilars

However, it is difficult to produce biologics identical to the reference biologics due to the complexity of the reference drugs. But, small molecules used as generic drugs can be synthesized identically by chemical synthesis. Moreover, the manufacturers of the biological drugs use their own procedures while producing the drugs, which are substantially similar to the reference drug. And, this results in an alternative biological drug, which is then approved as subsequent entry biologics (SEBs) or biosimilars. Since manufactures go backward, starting from the structure of the reference drug to produce a biosimilar drug, the manufacturing procedure is known as effectively reverse-engineered.

What are Biologics

Biologics are the biological products regulated under the rules of the Food and Drug Administration (FDA). They are used to either diagnose, prevent, treat, or cure various medical conditions. Significantly, biologics are large, complex, and diverse molecules produced through biotechnology. And, this uses living systems including animal cells, plant cells or microorganisms. Some examples of biologics are therapeutic proteins such as filgrastim, monoclonal antibodies such as adalimumab, vaccines such as those for influenza and tetanus, etc.

Figure 2: FDA’s Typical Drug Development and Approval Process

Moreover, the main challenge of manufacturing biologics is the consequent inherent variations. These variations of products have to be characterized with time. Therefore, the FDA assesses the manufacture’s strategy as well as the manufacturing procedure in order to control the product variations.

Similarities Between Biosimilars and Biologics

• Biosimilars and biologics are two types of biological products of drugs.
• Both types of medicines are complex molecules such as proteins produced through biological processes inside living cells.
• Therefore, the chemicals structure of the drug depends on the manufacturing process and factors as well as the types of cells used in the manufacturing process.
• Thus, all the manufacturers do not reproduce biological drugs which are identical to the reference drug.
• Besides, they are a type of the fastest-growing class of therapeutic products.
• They reduce the healthcare cost.

Difference Between Biosimilars and Biologics

Definition

Biosimilars refer to the biopharmaceutical drugs designed to have active properties similar to the one that has previously been licensed while biologics refer to biologic drugs produced from living organisms or contain components of living organisms. Thus, this is the main difference between biosimilars and biologics.

Correspondence

Another difference between biosimilars and biologics is that the biosimilars are a type of biologics similar to another biologic drug, which is already approved by FDA while biologics are medicines made up from living cells.

Significance

Moreover, biosimilars have no clinically meaningful difference in terms of safety and effectiveness with the reference product while the manufacturing of biologics is a highly complex process handled and administered under monitored conditions. Hence, this is another difference between biosimilars and biologics.

Conclusion

In brief, biosimilars are biological drugs similar to another FDA-approved biological drug by means of safety and effectiveness. Here, the FDA-approved drug is called the reference drug. On the other hand, biologics are the biological drugs made from living cells. Their manufacturing and administration is a carefully monitored procedure. Therefore, the main difference between biosimilars and biologics is their correspondence.

References:

1. “Biosimilars – Biosimilar and Interchangeable Products.” U S Food and Drug Administration, Center for Drug Evaluation and Research. Available Here

Image Courtesy:

1. “1112685” (CC0) via pxhere
2. “Figure 1: Food and Drug Administration’s (FDA) Typical Drug Development and Approval Process” By U.S. Government Accountability Office (United States government work) via Flickr