In August 2020, the company announced the launch of a further similar biologic on the domestic market. The drug, which is sold as NuPTH, is a similar biologic of teriparatide. It is a form of parathyroid hormone used to treat osteoporosis by promoting the formation of bone. According to 2003 data, there are 26 million people with osteoporosis in India. The drug can also be used in other patient groups at increased risk of fracture.

Cadila say the product, which comes as a pre-filled disposable pen, is easy to use which should encourage use among the elderly.

‘Difficulty in use and early drop-outs is often cited as a common reason for non-compliance of osteoporosis medication. The medication is primarily used by people of 50 years and above. We realized that if the delivery system is complex, people stop using it. The ease of use of delivery device is as important as development of new drugs’, commented Vice President of Cadila, Amit Ajmera.

Mr OP Singh, President of Sales and Marketing at Cadila, added: ‘With the launch of NuPTH we intend to strengthen our orthocare portfolio and help increase choice, and access for osteoporosis care to patients in the Indian Market. NuPTH builds new bones with ease, and we want all patients to have access to it’.

Later in August, Cadila announced the launch of a second similar biologic – and the fourth overall since July – an adalimumab biosimilar sold as Cadalimab.

Adalimumab is an antibody treatment for inflammatory conditions including various forms of arthritis, inflammatory bowel disease (IBD) and psoriasis. It was the first human monoclonal antibody treatment approved by the US Food and Drug Administration (FDA), where it has been sold under the brand name Humira since 2003.

According to Cadila, an estimated seven million people in India have rheumatoid arthritis and a significant portion of the population (up to 2.8%) also have psoriasis. ‘With the launch of Cadalimab, we want to reach these patients with a cost-effective solution and give them a chance at a better life’, said Mr Ajmera.

Cadalimab comes in a pre-filled syringe form to facilitate easy use. It is available in a 40 mg/0.8 mL injectable dose and has been shown to be effective in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that similar biologic approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Cadila Pharmaceuticals launches two similar biologics in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 2]. Available from: www.gabionline.net/Biosimilars/News/Cadila-Pharmaceuticals-launches-two-similar-biologics-in-India

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