Dr Reddy’s Laboratories has successfully completed the first phase of a study of a proposed biosimilar of tocilizumab, which is used to treat adult patients with moderate to severe active rheumatoid arthritis.
The study used a subcutaneous formulation to compare the equivalence of its tocilizumab biosimilar candidate with reference products.
Tocilizumab is used to treat moderate to severe active rheumatoid arthritis patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.
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The study met all primary and secondary endpoints and its pharmacokinetic equivalence, or biochemical similarity, to EU and US reference products was successfully demonstrated. The clinical trial found no noteworthy differences in safety and immunogenicity (the ability to generate an immune response) across three treatment groups, Dr Reddy’s said in an exchange filing on December 19.
Tocilizumab was approved for patients hospitalised with severe or critical Covid-19 in many parts of the world including India. The drug has also been recommended by the World Health Organization.
The successful outcome of the study was a key milestone in the company’s commitment to making biosimilar products more accessible and affordable around the world, Dr Reddy’s said. The company said it is developing the tocilizumab biosimilar as both subcutaneous and intravenous formulations.
Global study
Dr Reddy’s is now initiating a global study to compare the efficacy, safety, tolerability and immunogenicity of the proposed biosimilar with the reference product in patients with moderate to severe active rheumatoid arthritis.
Biosimilars are biologic medications that are generally made from natural sources and developed using advanced science, according to the US Food and Drug Administration’s website.
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Dr Reddy’s shares gained 2.06 percent to Rs 4,398 at the close on the BSE on December 19.
Swiss pharma company Roche and its subsidiary Genentech solely manufacture and sell tocilizumab under the brand Actemra/RoActemra. In India, tocilizumab is imported and distributed by generic drug company Cipla.
A Roche representative declined to comment on the price of the drug in India.
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“The drug currently costs Rs 38,000 per vial in India,” said Ashish Grover, secretary of the Delhi Drug Traders Association. “During the peak of the pandemic we saw the rates spiking very high as demand grew exponentially for this drug in India.”
In September last year, the Drug Controller General of India granted emergency use authorisation to Hetero Drugs Ltd. to sell its generic version of tocilizumab in India for the treatment of Covid-19.
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