Northeastern product as well as its mechanism

                                                Northeastern University-Boston     



between Biologics and Drugs

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                                                         Jacintha Saldanha






     RGA 6220


Anna Taranova

                                                          14 January 2018






           As per Section 351 of the Public
Health Service (PHS) Act, a biological product is defined as a “virus,
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or
derivative, allergenic product, or an analogous product applicable to the
prevention, treatment, or cure of a disease or condition in human beings.” A
biologic is manufactured in a living system like a microorganism or plant or
animal cells. Biological products include blood derived products, vaccines,
in-vivo diagnostic allergenic products, immunoglobulin products, products
containing cells or microorganisms and proteins. These innovations have
revolutionized the treatment of chronic illnesses like Crohn’s disease, Psoriasis
and Rheumatoid Arthritis to name a few, that do not respond to traditional
medicine. Commonly used biologics include insulin and Influenza vaccine. They are
large complex molecules or a mixture of such molecules. They also include
products derived through Recombinant DNA Technology.


        A drug is typically manufactured through chemical
synthesis, and its structures can be determined through laboratory procedures. Biologics
are manufactured via controlled procedures as these products are highly
sensitive to factors like temperature, microbial contamination, moisture, etc.

Their formulation includes insertion of a specific DNA sequence into clone
cells. Biologics require complex bioassays and stability assessment, rather than
chemical tests for identity and purity. Biologics targets specific areas of the
immune system unlike drugs which passes through various organs before reaching
the site of action. Bioavailability of biologics is higher than those of
traditional drugs as these are high efficiency and target specific products. Any
changes in the manufacturing processes of a drug can lead to an identical
finished drug product but the living cells used in the preparation of biologics
could be sensitive to minor changes in the manufacturing process leading to a
huge impact on the final product as well as its mechanism of action and its
effect on the human body. Biologics are always manufactured in aseptic
conditions to avoid contamination, in contrast to drugs. Due to its sensitive
and complex nature, it is very difficult to produce a biologic with 100%
accuracy the second time. Hence, owing to these conditions and highly efficient
machinery used in the formulation of these products, the cost of manufacturing
biologics is much higher as compared to drugs. Also, even after making use of
state of the art equipment and controlled conditions, the batch and quantity of
the product is really small and are also expensive. This could be one of the
reasons why investors prefer drug companies over biologics.


       Biologics are also said to have lesser side
effects. The most common side effects include pain and rash at the site of
injection and some people may also experience allergenic infusion reactions
like nausea, vomiting, fever, chills. However, as now a days, most biologics
are administered through the parentral route of administration, they have short
plasma half lives resulting in frequent administration and decreased patient


may also be termed as drugs under the Food, Drug and Cosmetics Act. These
products include Insulin, Glucagon and Human Growth Hormone. There are two
centres which are responsible for reviewing Biological products, namely, Centre
for Drug Evaluation and Research (CDER) and Centre for Biologics Evaluation and
Research (CBER).  CDER, under the FDA,
regulates over the counter and prescription drugs including biologics and
generics, and also safeguards public health by ensuring safe and effective
drugs are available to the public. Meanwhile, CBER is the Centre within the FDA
that regulates biological products for human use under federal laws including
the FDC Act and the PHS Act. Products under CDER include Monoclonal Antibodies,
Proteins like enzymes, cytokines and immunomodulators. CBER regulates Blood and
Blood products, Cellular and Gene Therapy products, Vaccines, tissues and
tissue products. Combination products are regulated depending on individual
products as well as its primary mode of action. If the product’s primary mode
of action is similar to a product belonging to CDER, it will be regulated by
the same. Whereas, a product with its primary mode of action similar to that of
a product governed by regulations of CBER, it will be regulated by CBER.

conclude, I would like to say that irrespective of efficacy and low side
effects, the only disadvantage of biologics are that they are expensive and
possess low patient compliance which seems to be the advantage in the context
of drugs.
















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