Express Pharma

Biocon Biologics denies bribery allegations

A statement from the company claimed that besides its employees, all its consultants, suppliers and partners are also bound by a strong code of conduct that has a detailed clause on anti-bribery and anti-corruption

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Biocon Biologics has denied the allegations of bribery against the company and its officials associated with the approval process of one of its products in India.

“Biocon Biologics is governed by a strong code of conduct. We strongly condemn any acts of corruption and violation of rules by way of offering or paying bribes or undue favours, either directly or indirectly. We adopt global best practices in corporate governance and business responsibility,” the company said in a statement issued yesterday.

The statement claimed that besides its employees, all its consultants, suppliers and partners are also bound by a strong code of conduct that has a detailed clause on anti-bribery and anti-corruption.

Regarding seeking the waiver of phase-III clinical trials for insulin Aspart in India, the statement said, “All our product approvals are backed by science and clinical data. The rationale for waiver of phase-III clinical trials was based on the following Indian regulatory guidance {Similar Biologics Guidelines 2016 & New Drugs and Clinical Trials 2019 (GSR 227 E)}.”

It further added, “The guidelines provide a framework for waiver of phase-III clinical trials to be conducted in India based on a commitment to undertake a phase-IV trial, the design of which should be approved by the Central Licensing Authority.

“In line with the above regulations, Biocon Biologics presented a proposal for import and marketing of Insulin Aspart with a waiver of phase-III clinical trial in India. The company presented a detailed proposal along with CMC, pre-clinical and clinical trial data.”

The Subject Expert Committee (Endocrinology and Metabolism) in its meeting held on 18th May, 2022 at CDSCO, New Delhi, noted that Biocon Biologics has conducted phase-I and phase-III trials with Aspart in Germany and the US, respectively, and based on the results of this global trial, Biocon Biologics’ product, Aspart, has been granted marketing authorisation by EMA and Health Canada, according to the statement.

“After detailed deliberation, the committee recommended for grant of permission to import and market the drug with waiver of phase-III clinical trial in the country with the condition that firm should conduct phase-IV clinical trial in India (which also includes a sub-set population to generate PK/PD and immunogenicity and submit the protocol to CDSCO before placing the drug in the market) as per the existing guidelines in the country,” the SEC concluded, as per the statement.

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