Analyzing Generics Biologics and Biosimilars

Generics, Biologics, and Biosimilars

Properties of Generic Drugs, Biologics, and Biosimilars, with Examples and Usage

Generic drugs

Generic drugs denote pharmaceutical products that are typically meant to be substituted with some innovator product manufactured with no license from innovator, and sold in the markets after exclusive rights (such as patents) expire (WHO, 2016). Some of the properties of these drugs include;

Generic drugs are usually sold at prices considerably lower than branded price; and They are bioequivalent or identical to branded drugs in their strength, form, dosage, safety, quality, administration route, intended use, and performance characteristics.

Some generic medicine examples, together with their usage:

Paracetamol: this is the chemical constituent of numerous branded painkillers; it is, however, marketed as generic medicine, too, and utilized for pain alleviation.

Ibuprofen: his is employed for reducing fever and treating inflammation (swelling/irritation) or pain resulting from a number of conditions, including headache, back ache, toothache, minor injury, arthritis, or menstrual cramps.

1. Penicillin G: this drug is utilized for treating a wide range of bacterial illnesses. Further, it is utilized for preventing bacterial endocarditis or heart infection.

Biologics

Biologics are produced within animal/plant cells, microorganisms, and other living systems. A majority of these are rather complex and large molecules, or a mix of molecules. Numerous biologics are manufactured through the use of genetic engineering (Bio.org, 2010). Biologics have the following properties;

1. Typically, biologics are between 200 and 1,000 times a tiny molecule/chemical drug's size; their structure is much more complex than that of chemical drugs or molecules

1. They are highly pH- and temperature- sensitive, and thus, their large-scale production or characterization is relatively difficult (Amgen, 2015).

Examples: Actemra, Enbrel, and Cimzia. All these are used for rheumatoid arthritis treatment.

Biosimilars

Biosimilars are biological products approved on the basis of proof that they are extremely similar to some biological product (i.e., reference product) approved by the Food and Drug Administration, and don't have any clinically significant differences from their corresponding reference products in regards to effectiveness and safety. Only very small differences present in their clinically inactive elements are allowed in biosimilars (FDA, 2015). Their properties include the following;

1. They don't have any clinically significant differences from their corresponding reference products in regards to effectiveness and safety

1. Their source is living organisms

1. Their action mechanism must be identical to that of their corresponding reference product

A few examples of biosimilar products:

1. Avastin: This drug is utilized in lung cancer treatment

1. Cerezyme: This drug is utilized in Gaucher disease treatment

1. Filgrastim: This is applied in stimulating granulocyte differentiation and proliferation

Criteria That Generic Drugs and Biologics Must Satisfy Before They Are Allowed to Come to Market

Generic Drugs

ANDA (Abbreviated New Drug Application), containing information that when presented before the drugs are submitted to the Office of Generic Drugs of Food and Drug Administration's Center for Drug Evaluation and Research, reviews and ultimately approves of generic medicine. After approval, applicants can produce and sell the generic medicine, offering the U.S. public an effective, safe, and economical alternative. General ANDA requirements include: labeling, legal requirements, microbiology and chemistry, and bioequivalence (FDA, 2015).