Intas launches etanercept biosimilar in India

March 27, 2015 11:21 AM

Intas Pharmaceuticals announced that they have launched Intacept, the first biosimilar to Amgen’s Enbrel.

Intacept, Intas’ etanercept, has been launched in two strengths, 25mg in 0.5 ml and 50 mg in 1.0 ml preservative free solution, in easy to use pre-filled syringes. Etanercept is indicated for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Plaque Psoriasis, all debilitating autoimmune diseases.

Mr. Binish Chudgar, Vice-Chairman of the Company, said, “Etanercept is a fusion protein that is difficult to develop. Intacept is a further validation of our world-class R&D and manufacturing capabilities that bring global healthcare standards to Indian patients at a lower cost. Through Intacept, we are able to reduce the cost of treatment for patients to about half of the imported Enbrel®.”

Intas is one of the market leaders of biosimilars in India, having launched its first product in the domestic market in 2004. With the launch of Intacept, the company now has nine biosimilar products in the market, including one monoclonal antibody Mabtas (rituximab), the largest indigenously development portfolio of biosimilar products. The company continues to have one of the richest pipeline of future products, thereby ensuring cost effective biosimilar alternates to imported and expensive biologic therapies.

Intas is also the only company from India to have registered and launched a biosimilar in the highly regulated European market. Its first biosimilar for global markets, Accofil (filgrastim) was launched in Europe in January this year. The company’s biosimilar manufacturing facilities have been approved by global regulatory agencies such as EMA, ANVISA, WHO and others. Intacept is also produced in the same manufacturing facilities as its other biosimilars. In addition, Intas is also the only company from India to have two of its biosimilars, filgrastim and peg-filgrastim filed for registration in the US.

Editor’s note: Back in 2013 Cipla declared the launch of first etanercept biosimilar which was sourced from China. Now an another Indian company, Intas declares that, Intacept is the first etanercept biosimilar in India.

Any information about the “first” etanercept and development of this product would be appreciated. Please use the comment section below or our Linked In Group to send your comments.

Source: Intas Pharmaceuticals press release

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