Swiss pharmaceutical company Roche has sounded the alarm over Zydus Lifesciences’ clinical trials of its biologic drug Perjeta, a widely used breast cancer treatment. The Swiss company has filed a lawsuit against the Indian drugmaker, alleging serious flaws in its clinical trials of a drug originally developed by Roche.
Global biotech giant Roche has claimed that the drug used by Zydus in the initial stages of clinical trials was not sourced from them and therefore may be of “questionable quality”, “damaged” or “counterfeit”.
Ahmedabad-based Zydus, however, believes the move is an attempt to “damage” its reputation and “discredit” its achievements in providing expensive medicines at affordable prices in the Indian market.
On November 24, Roche wrote to the Drug Controller General of India (DCGI), urging the regulatory agency to intervene and investigate the issue. On February 7, it reiterated this request. News18 has seen the letter titled “Import of Innovator reference biologic drug Perjeta for clinical trials in India”.
Roche said the matter was related to “patient safety” and had asked the country’s top health regulator DCGI to “ask Zydus whether it procured all Perjeta (Pertuzumab) for clinical trials from authorized sources.”
A senior government official with knowledge of the development confirmed a complaint had been received and told News18 the matter was under investigation and internal meetings were ongoing.
A Zydus spokesperson denied the allegations in an email to News18, calling them “baseless”. The Ahmedabad-based company said it “remains committed to sharing relevant information with regulators where required”.
“Zydus has been successfully conducting trials and launching critical NCEs, novel biologics and biosimilars, many of which are first-in-India and first-in-the-world products. All necessary regulations on ethics and safety are followed while conducting clinical trials and process.”
“We remain committed to sharing relevant information with regulators where required. These allegations are baseless and baseless. Despite efforts to defame and discredit us, we remain committed to making unaffordable and expensive medicines available to cancer patients in India. Biosimilars.”
Multicenter trial of 268 patients
The trial received regulatory clearance from DCGI on December 31, 2021, in patients with “breast malignancies of unspecified site”, according to the clinical trial protocol available on the Clinical Trials Registry of India (CTRI). It refers to a cancerous growth in the breast but does not specify the specific location within the breast.
The comparator, or comparator, used in the clinical trial was Roche’s brand Perjeta, while the intervention drug tested was Zydus’ drug, labeled ZRC-3277.
CTRI showed that Zydus successfully completed the final enrollment of 268 patients, and the trial began in September 2022. According to CTRI, the multi-center trial is being conducted at more than 40 sites in India, including All India Institute of Medical Sciences (AIIMS), New Delhi, Rajiv Gandhi Cancer Institute and Research Centre, Tata Memorial Hospital in Mumbai, and Mumbai KR Hospital, Sol Medical College and Research Institute.
Allegations and Resolution
In an email to News18, Roche highlighted a mismatch in timelines for the procurement of its drug Perjeta for clinical trials. The company’s purchasing data suggests Zydus may not have purchased the drug from the originator at the start of the trial.
“Zydus procured 480 vials of the original innovative reference product (Perjeta) from Roche Pharmaceuticals India in January 2023,” a company spokesperson said, adding that Zydus did not purchase trial vials from Roche Pharmaceuticals in 2022.
The clinical trial begins in September 2022, according to CTRI.
“This therefore raises important questions – whether the reference product imported in 2022 is of questionable quality (possibly compromised/counterfeited), what supply chain norms were followed (security, cold chain, etc.) and the credibility of the earlier sources.” Speaks People say it will be imported in 2022.
Dr Amitav Banerjee, professor of community medicine at DY Patil Medical College, Pune, said, “This is an open and closed case.”
“Regulators must ask Zydus to clarify the batch numbers and where they extracted the product from and imported it. Roche should then verify these details from the records of its authorized distributors. Everything will be clear within a day and no lengthy investigation is required.” ”
Banerjee had headed the clinical trials ethics committee of the National Institute of Virology in Pune. Currently, he is the Chairman, Ethics Committee, Armed Forces Medical College, Pune.
“DCGI should refer the matter to the ethics committee to review the trial. Once they ask the company, they must declare the source of the control drug.”
Dr. Anant Bhan, a researcher in bioethics and health policy, said: “The controversy surrounding clinical trials involves many aspects, including competition between multinational companies and domestic pharmaceutical companies, regulatory and ethical oversight, good clinical practice and other issues.”
Barn added that for the sake of science and credibility, regulators should examine the issues raised and respond formally, prioritized and in a transparent manner.
News18 sought official comment from DCGI but has not received a response so far. This report will be updated if DCGI responds.
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