Drug maker Cipla has locally rolled out its first biosimilar, Etanercept, used to treat rheumatic disorders.
Formed through a partnership alliance, the drug sold under the Etacept brandname will be manufactured by China-based Shanghai CP Guojian Pharmaceutical Co and marketed by Cipla in India, a note from Cipla said.
The introduction of Etacept now signals Cipla’s entry into the biologics segment offering an option to the patients suffering from rheumatic disorders at a lower cost.
Rheumatic disorders are chronic inflammatory disorders affecting the joints, characterised by pain, redness, swelling and loss of function in several joints. It can lead to joint damage and deformities.
If left undiagnosed and untreated, this could lead to permanent disability and at times could lead to mortality. However, rheumatic disorders can be controlled by early diagnosis and treatment, the note explained.
Etacept is available as a powder to be given by subcutaneous injection, and is available with stockists across the country at Rs 6,150.
Cipla’s Medical Director Dr Jaideep Gogtay said: “The higher cost of biologics has been a major hindrance, limiting its affordability and accessibility to millions of patients. We believe that introducing Etacept at a lower cost (30 per cent lesser compared to the innovator) will enable access of this drug to a greater number of patients in India. This can be enhanced further if we consider the results of a recent study that showed in patients, who were successfully treated with Etanercept for six months, a 50 per cent reduced dose worked just as well as continuing the current dose.”
Anti-rheumatic drugs
At present, there are disease-modifying anti-rheumatic drugs which are considered to be the first line of treatment for rheumatic disorders. However, approximately 40 per cent of the patients are not controlled on these drugs.
In such cases, biologics like Etanercept play a significant role in controlling the disease activity and make a positive difference in the lives of these patients, the company said.
Inflammation, joint damage
Etacept contains Etanercept, a biologic produced by recombinant DNA technology. Etacept (Etanercept) binds to TNF-α, a cytokine that plays a very important role in inflammation and joint damage in rheumatic disorders. It helps in modifying the course of the disease and prevents further damage to the joints.
Etacept (Etanercept) is approved in the management of rheumatic disorders like Rheumatoid Arthritis, Ankylosing Spondylitis, Juvenile Idiopathic Rheumatoid Arthritis and Psoriatic Arthritis, the company said.
Since its launch in 2006 in China by Shanghai CP Guojian Pharmaceutical Co, over 50,000 patients have been treated with Etanercept. Clinical efficacy and safety of the drug have also been well established in Indian patients, Cipa said.
What is rheumatic disorder?
Rheumatic disorders are chronic inflammatory disorders affecting the joints, characterised by pain, redness, swelling and loss of function in several joints.
It can lead to joint damage and deformities.
If left undiagnosed and untreated, this could lead to permanent disability and at times could lead to mortality.
However, rheumatic disorders can be controlled by early diagnosis and treatment, the company explained. At present, there are disease modifying anti-rheumatic drugs which are considered to be the first line of treatment for the problem.
However, approximately 40 per cent of the patients are not on these drugs.
In such cases, biologics like Etanercept play a significant role in controlling the disease and make a positive difference in the lives of these patients.