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'Generic' Version of Biologics Appear to be Similar to Their Brand-Name Analogues

Health In Focus   - G J E 4
Highlights
  • Biologics or biological agents are produced from natural sources or living cells.
  • They are considered to be the future and fastest-growing sector in the pharmaceutical market.
  • A new analysis by Johns Bloomberg School of Public Health suggested that biosimilars of Tumor Necrosis Factor alpha (TNF-alpha) inhibitors used in the treatment of auto-immune diseases are cheaper and equivalent to their brand-name counterparts.

The biosimilar versions of the Tumor Necrosis Factor alpha (TNF-alpha) inhibitors used in the treatment of rheumatoid arthritis, psoriasis and inflammatory bowel disease are found to be comparable to their brand name equivalents. The findings of the study published in 'The Annals of Internal Medicine' indicate that the generic version of biologics, or biosimilar drugs, are cheaper and comparable to their brand name drugs in terms of efficacy and safety.
'Generic' Version of Biologics Appear to be Similar to Their Brand-Name Analogues
'Generic' Version of Biologics Appear to be Similar to Their Brand-Name Analogues
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Biologics - An Innovation

Biologics are pharmaceutical products obtained from natural sources mainly living cells. They may beisolated from humans, animals or micro-organisms like bacteria and yeast and are usually produced by biotechnological methods or other innovative procedures. Vaccines, blood and blood-related components, and gene therapy and recombinant therapeutic agents are some of the biological agents that are available.

‘Study findings suggest that generic version of biologics are cheaper and equivalent in terms of safety and efficacy to their brand-name drugs.’
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Biologics prove to be an excellent and effective treatment option for a variety of medical conditions. Aseptic techniques have to be followed while manufacturing biologics to prevent microbial contamination. Biologics seems to be the fastest growing sector in the pharmaceutical industry.


Study Findings on Generic Vs Brand-Name Biologics:

Generic drugs are a copy of brand name drugs and are cheaper and therefore within the reach of more patients. They are usually developed when the patent of the existing drug expires. On the other hand, biological agents are made up of large number of complex molecules which makes it difficult to replicate or produce an exact copy of the drug. This inturn will lead to the formation of biosimilar drugs.

The study analyzed data collected from scientific literature which compared brands of Tumor Necrosis Factor alpha (TNF - alpha) inhibitors with biosimilar forms. The data findings were based on 19 studies conducted in April 2016. The Tumor Necrosis Factor alpha inhibitors (TNF - alpha ) are a class of drugs which are used in the treatment of autoimmune diseases like rheumatoid arthritis, psoriasis and inflammatory bowel disease. The researchers found that the safety and efficacy of the biologicals and their biosimilar counterparts appear to be similar.

Biologics and Biosimilars - The Future of the Pharmaceutical Market:

The United States Food and Drug Administration approved TNF alpha inhibitor inflectra which is a biosimilar for infliximab. Other branded biologics and their biosimilars are also approved in Canada, Asia and Europe.

Dr. GC Alexander, the leader of the study hoped that their study, based on the comparison of biosimilar TNF alpha inhibitors with the brand name drugs, should assure physicians, patients and healthcare systems that they are comparable.

He also suggested that more research related to other biological products like insulin should be carried out to compare the effectiveness of the biosimilar forms with their branded counterparts. Biologics are the future of the pharmaceutical market in the coming years and a cheaper and yet equally effective and safe will definitely benefit the patient.

References:
  1. Introduction to Biosimilars - (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologic
    -Applications/Biosimilars/ucm241718.htm)
Source: Medindia
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