Approval of more than 18 recombinant drugs by European Union and nine recombinant drugs by Food and Drug agency in 2019, highlights the emergence and competition in the field of marketing of new therapeutic biological medical products. Biologics or biopharmaceuticals or biological medical product are the pharmaceutical drugs which mimics natural biological substances produced in living cells through biological process. Biologics includes various pharmaceutical products derived from living cells using biotechnology. After approval and successful marketing of first biologic named humulin (Recombinant insulin) in 1982, recombinant erythropoietin, recombinant somatotrophin and granulocyte colony-stimulating factor were also soon launched in global market and were historical for the management of respective chronic conditions. Till 1980, more than 150 biologics has been approved and marketed around the globe. These biologics becomes very popular since their introduction inspite of involved high prices as they are major breakthrough in the treatment of many chronic fatal diseases. Even various biologics has been approved for marketing in the field of Veterinary drugs too. These includes recombinant interferon omega for canine parvoviral enteritis and feline leukaemia, protamine zinc insulin for diabetes, feline interleukin-2 for feline sarcoma and pegbovigrastim for prevention of bovine clinical mastitis. USDA approved veterinary immunostimulant preparation are Propionibacterium acne (Eqstim) and polyprenyl (Vetimmune). Lokivemetab is only biologic monoclonal antibody approved for veterinary use in treatment of canine atopic dermatitis. Approaching expiry of patent of biologics which were marketed in 1980s, leads to the introduction of second generation biologics which are copy drugs of these generic biologics and intends to offer comparable quality, efficacy, safety that too at low prices. These drugs are popularly known as Biosimilar drugs or similar biological product (SBP) or follow on biologic (FOB) or subsequent entry biological (SEB). Biosimilar approved for therapeutic use includes recombinant proteins, monoclonal antibodies, hormones, interleukins, antitoxin and vaccines.
References
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EC Pharmacology and Toxicology
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