Cipla launches first biosimilar etanercept in India

April 18, 2013 9:03 AM

cipla biosimilarnews logo Cipla launches first biosimilar etanercept in India

Cipla, India’s leading generic pharmaceutical companies announces the launch of the first biosimilar of etanercept in India; under the brand name ‘ETACEPT’ for the treatment of rheumatic disorders.

Formed through a partnership alliance, Etacept is manufactured by a China-based company Shanghai CP Guojian Pharmaceutical Co. Ltd., which will be marketed by Cipla in India. Over the 75 years, Cipla has established itself as a leader in many disease areas such as respiratory, cardiology, urology and anti-infectives including HIV/AIDS and of late has been aggressively developing the product pipeline in emerging therapies like Oncology, Rheumatology, Pulmonary Arterial Hypertension, Hepatology etc. The introduction of Etacept now signals Cipla’s entry into the biologic segment offering an option to the patients suffering from Rheumatic disorders at a lower cost.

Rheumatic disorders are chronic inflammatory disorders affecting the joints, characterized 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.

Currently there are DMARDs (Disease modifying anti-rheumatic drugs) which are considered to be the first line of treatment for rheumatic disorders. However, approximately 40% 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.

Etacept contains Etanercept, a biologic produced by recombinant DNA technology. Etacept binds to TNF-alfa, a cytokine that plays a very important role in the inflammation and joint damage in rheumatic disorders. It helps in modifying the course of the disease and prevents further damage to the joints. Etacept is approved in the management of rheumatic disorders like Rheumatoid Arthritis, Ankylosing spondylitis, Juvenile Idiopathic Rheumatoid Arthritis and Psoriatic Arthritis.

Since its launch in 2006 in China by Shanghai CP Guojian Pharmaceutical Co. Ltd., over 50,000 patients have been treated with etanercept. Clinical efficacy and the safety of the drug have also been well established in Indian patients.

 

Editor’s note: According to the press release, we can understand that, Etacept is not developed in accordance with the global guidelines. Like Reditux approval, back in 2007, India has approved an another biosimilar which can not be marketed in “regulated” markets like EU, US, Canada, Australia, etc.

Source: Cipla press release

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