Golimumab

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PART A

Simponi ® (Golimumab) (Almeida, Amaral, and Lobão, 2011)

It acts as a TNF inhibitor therefore is used to treat symptoms of some disorders of the human autoimmune system. These will include psoriatic arthritis, rheumatoid arthritis and ulcerative colitis. (What is golimumab and why is it prescribed, 1998)

TNF alpha is the acronym for the protein tumour necrosis factors – alpha. The human immune system will form this protein in the body naturally. However, too much of this protein will attack parts of the body causing pain and swelling. Golimumab binds to excess protein TNF – alpha and blocking the action of it. The drug can form binding with various type of tumor necrosis factor alpha and also binds to different locations of the protein. However, blocking too much of TNF – alpha may decrease one’s body to fight off infections. Golimumab is administered through injection using a device SmartJect ® by Simponi ®.

(How does SIMPONI® work to target and block TNF in moderate to severe RA? – SIMPONI®,2013)

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Figure 1. Illustration showing the binding of Simponi ® (Golimumab) to two forms of TNF – alpha

This product is a monoclonal antibody of the human immunoglobin G1kappa. Golimumab is produced with technology involving mice which are engineered genetically which undergoes immunization of human TNF alpha. Full human antibodies will be expressed in the end. It also involves a recombinant cell line. (CHMP, 2009)

Clinical trials for Golimumab started on February 2007 and the primary completion date was on August 2007. The first received date was on 3rd March 2006 and the first results were received on 21st of May 2009. Centocor, Inc. submitted the BLA to the FDA for Golimumab for treatment of diseases involving the human autoimmune system on 27th June 2008. FDA approves Simponi ® (Golimumab) as an anti TNF treatment which are administered once a month to treat the aforementioned diseases on 24th April 2009. On 15th May 2013, the FDA gave an approval to Simponi as a treatment for ulcerative colitis. Golimumab for infusion receives FDA approval to treat moderate to severe active rheumatoid arthritis. (Simponi (golimumab) FDA approval history, 2000) (A study of the safety and efficacy of Golimumab (CNTO 148) in subjects with active rheumatoid arthritis previously treated with biologic Anti-TNFa agent(s) - Tabular view, 2006)

PART B

In order to complete this given task, I utilised the internet to search for a biotechnological drug using search engines such as Google. This leads me to a few websites and pdf files which I used to obtain my topic for discussion. I decided to use the drug Simponi® which is Golimumab.

Once I have found the drug of my choice, I further searched for more information of the drug using Google to get a general idea of what the drug does and decide whether is it suitable to be a topic for this task. For this, I got a brief introduction of this drug by browsing through Wikipedia articles.