Cadila Puts a Teriparatide Biosimilar on the Market

Tony Hagen

Tony Hagen is senior managing editor for The Center for Biosimilars®.

Cadila Pharmaceuticals charges ahead with yet another biosimilar launch in India, an osteoporosis agent referencing Eli Lilly's teriparatide drug Forteo.

Cadila Pharmaceuticals, of Ahmedabad, India, has launched a teriparatide biosimilar (NuPTH) indicated for osteoporosis and in patients with increased risk of fracture. The drug references Forteo, made by Lilly.

“India is the osteoporosis capital of the world,” Cadila said in a release indicating the company’s hopes pinned to this product and its potential. The company cited study data that estimated the population of individuals with osteoporosis in India measured 26 million. “It is estimated that by 2050, half of the world’s fractures will occur in Asia.”

The launch of NuPTH is the third biosimilar launched in as many weeks by Cadila, which in late July put 2 biosimilars on the market: a rituximab (Ritucad) for the treatment of blood cancer and rheumatoid arthritis, and a bevacizumab (Bevaro) for the treatment of ovarian cancer, glioblastoma multiforme, colorectal cancer, breast cancer, lung cancer, cervical cancer, and kidney cancer.

Cadila said it will market teriparatide in a prefilled disposable pen, which is said would be both cost-effective and easy to use, thereby circumventing the tendency for patients to discontinue use if the delivery method is too complex. “The ease of use of delivery device is as important as development of new drugs,” according to Amit Ajmera, vice president of Cadila.

The company said the product strengthens its orthocare portfolio and helps to increase choice and access for patients with osteoporosis in India.

The First Treatment That Regrew Bone

Teriparatide, a recombinant human parathyroid hormone, was the first osteoporosis treatment that stimulated the development of new bone similar to normal bone.

Osteoporosis occurs in postmenopausal women as a result of bone deterioration, or resorption, that is not accompanied by an equivalent level of new bone formation. Teriparatide has also been used for treatment of men with hypogonadal (excessive hormone production) or idiopathic (unknown causes) osteoporosis.

There has been some uncertainty about the length of time patients should be treated with teriparatide. A 2016 study evaluated a 24-month course of the drug from the perspective of effects on bone tissue, bone replacement in resorption sites, and safety and fracture outcomes.

Investigators noted an improvement in outcomes for patients who took the full 24-month course and found that bone formation appeared to occur continuously during the entire period, “resulting in increases in bone mass, even in patients with low bone turnover induced by long-term previous anti-resorptive treatment.”

They concluded that, for patients on teriparatide, improvements in bone mass and strength and reduction in risk of fracture correspond to the length of treatment.