April 17, 2013 | By Márcio Barra
Cipla, the Indian generic drug maker, has entered the biosimilar market, as they just launched the first biosimilar of Pfizer and Amgen’s rheumatic disorder blockbuster Enbrel (Etarnecept) in India, under the brand name Etacept.
Being a generic, it will sell for cheaper than Enbrel in India, at 6,150 rupees, 30% less than the innovator product, which “will enable access of this drug to a greater number of patients in India”, said Cipla’s Medical director Jaideep Gogtay.
Etanercept is a fusion protein created through recombinant AND, acting as TNF – inhibitor by mimicking the inhibitory effects of naturally occurring TNF receptors. TNF, or Tumor Necrosis Factor, is a cytokine responsible for many of the body’s inflammatory reactions, like rheumatoid arthritis and ankylosing spondylitis. Enbrel has a recommended dosage of 25 mg twice-weekly by subcutaneous injection.
Enbrel was 2012’s second-best-selling drug in the world, with estimated worldwide sales of $8.37 billion, behind Humira, from Abbot’s pharmaceuticals.
As generic companies in India start to enter the biosimilar market, pressure is surely to mount for pharma companies, seeing as biosimilars are regarded as a tough, if lucrative (biologic patents worth $54 billion are set to expire between 2011 and 2020) market. Few biosimilars are available in Europe, with 14 biosimilars approved by EMA to date, and the US is still creating their biosimilar regulation. More Indian companies are sure to follow in Cipla’s footsteps.