Cipla launches first biosimilar drug for rheumatic disorders

Generic drug maker Cipla today announced the India launch of the first biosimilar of Etanercept, which is used for treatment of rheumatic disorders.

Cipla said the biosimilar, `Etacept', developed through a partnership alliance with China-based Shanghai CP Guojian Pharmaceutical Co Ltd, would be marketed by Cipla in India.

Shanghai CP Guojian Pharmaceutical Co will manufacture `Etacept', while Cila will market the drug in India, Cipla said in a note.

Etacept, which signals Cipla's entry into the biologics segment, will offer patients suffering from rheumatic disorder a low-cost treatment option.

''We believe that introducing Etacept at a lower cost (30% lesser as 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 6 months, a 50% reduced dose worked just as well as continuing the current dose,'' Dr Jaideep Gogtay, medical director of Cipla said.

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.

While it can be controlled by early diagnosis and treatment, if left undiagnosed and untreated, this could lead to permanent disability and at times could lead to mortality.

The currently available disease modifying anti-rheumatic drugs (DMARDs), which are considered to be the first line of treatment for rheumatic disorders, fail in the case of approximately 40 per cent of the patients.

In such cases, biologics like Etanercept, including biosimilar `Etacept,' play a significant role in controlling the disease activity and make a positive difference in the lives of these patients, Cipla said in a release.

Since its launch in 2006 in China by Shanghai CP Guojian Pharmaceutical Co Ltd, the drug has been used to treat over 50,000 patients. Clinical efficacy and the safety of the drug have also been well established in Indian patients, Cipla said.

Etacept is available as a powder to be given by subcutaneous injection. Available with stockists across the country, it is priced at Rs6,150 and the recommended dose for adults is 25mg twice weekly.