Northeastern University-Boston Differencesbetween Biologics and Drugs Jacintha Saldanha RGA 6220 Dr.Anna Taranova 14 January 2018 As per Section 351 of the PublicHealth Service (PHS) Act, a biological product is defined as a “virus,therapeutic serum, toxin, antitoxin, vaccine, blood, blood component orderivative, allergenic product, or an analogous product applicable to theprevention, treatment, or cure of a disease or condition in human beings.” Abiologic is manufactured in a living system like a microorganism or plant oranimal cells. Biological products include blood derived products, vaccines,in-vivo diagnostic allergenic products, immunoglobulin products, productscontaining cells or microorganisms and proteins.
These innovations haverevolutionized the treatment of chronic illnesses like Crohn’s disease, Psoriasisand Rheumatoid Arthritis to name a few, that do not respond to traditionalmedicine. Commonly used biologics include insulin and Influenza vaccine. They arelarge complex molecules or a mixture of such molecules. They also includeproducts derived through Recombinant DNA Technology. A drug is typically manufactured through chemicalsynthesis, and its structures can be determined through laboratory procedures. Biologicsare manufactured via controlled procedures as these products are highlysensitive to factors like temperature, microbial contamination, moisture, etc.
Their formulation includes insertion of a specific DNA sequence into clonecells. Biologics require complex bioassays and stability assessment, rather thanchemical tests for identity and purity. Biologics targets specific areas of theimmune system unlike drugs which passes through various organs before reachingthe site of action. Bioavailability of biologics is higher than those oftraditional drugs as these are high efficiency and target specific products. Anychanges in the manufacturing processes of a drug can lead to an identicalfinished drug product but the living cells used in the preparation of biologicscould be sensitive to minor changes in the manufacturing process leading to ahuge impact on the final product as well as its mechanism of action and itseffect on the human body. Biologics are always manufactured in asepticconditions to avoid contamination, in contrast to drugs. Due to its sensitiveand complex nature, it is very difficult to produce a biologic with 100%accuracy the second time. Hence, owing to these conditions and highly efficientmachinery used in the formulation of these products, the cost of manufacturingbiologics is much higher as compared to drugs.
Also, even after making use ofstate of the art equipment and controlled conditions, the batch and quantity ofthe product is really small and are also expensive. This could be one of thereasons why investors prefer drug companies over biologics. Biologics are also said to have lesser sideeffects. The most common side effects include pain and rash at the site ofinjection and some people may also experience allergenic infusion reactionslike nausea, vomiting, fever, chills. However, as now a days, most biologicsare administered through the parentral route of administration, they have shortplasma half lives resulting in frequent administration and decreased patientcompliance.
Biologicsmay also be termed as drugs under the Food, Drug and Cosmetics Act. Theseproducts include Insulin, Glucagon and Human Growth Hormone. There are twocentres which are responsible for reviewing Biological products, namely, Centrefor Drug Evaluation and Research (CDER) and Centre for Biologics Evaluation andResearch (CBER).
CDER, under the FDA,regulates over the counter and prescription drugs including biologics andgenerics, and also safeguards public health by ensuring safe and effectivedrugs are available to the public. Meanwhile, CBER is the Centre within the FDAthat regulates biological products for human use under federal laws includingthe FDC Act and the PHS Act. Products under CDER include Monoclonal Antibodies,Proteins like enzymes, cytokines and immunomodulators. CBER regulates Blood andBlood products, Cellular and Gene Therapy products, Vaccines, tissues andtissue products. Combination products are regulated depending on individualproducts as well as its primary mode of action. If the product’s primary modeof action is similar to a product belonging to CDER, it will be regulated bythe same. Whereas, a product with its primary mode of action similar to that ofa product governed by regulations of CBER, it will be regulated by CBER.
Toconclude, I would like to say that irrespective of efficacy and low sideeffects, the only disadvantage of biologics are that they are expensive andpossess low patient compliance which seems to be the advantage in the contextof drugs. REFERENCES:· “What are ‘Biologics’ Questionsand Answers”, U.S. Food & Drug Administration Home Page. Accessed January12, 2018.
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