Roche questions Zydus on clinical trials for its breast cancer drug Perjeta (Pertuzumab), ET HealthWorld

[ad_1]

Mumbai: Roche, the world’s top seller of oncology drugs, has raised red flags against the clinical trials conducted by Indian drug maker Zydus Lifesciences on Perjeta (pertuzumab), its popular breast cancer treatment. The Swiss drug maker has alleged that 500 vials of the drug were sourced from questionable channels for clinical trials in India.

If the allegations are investigated and proven by the central drug regulatory authorities, it may snowball into a major controversy regarding the standards of clinical trials being followed in India. A significant bounce has lately been seen in clinical trials in India following a prolonged phase of subdued interest by multinational drug makers.

Sharing details with ETPharma, Roche spokesperson noted the imports made by Zydus from Germany between August and September 2022 were not from its official supply chain. That in turn, the company says raises important questions: whether the reference products were of questionable quality—possibly compromised/spurious or what supply chain norms such as safety and cold chain were followed, and the credibility of the source from where the imports were made.

Zydus Lifesciences has not responded to detailed questions from ETPharma, despite several reminders and follow-ups. Any updates from Zydus, when received, will be included in the story. The issue was also raised with the Drug Controller General of India (DCGI), and as of this writing, there has been no response from the DCGI office.

According to government data, Zydus applied for a grant of permission to conduct a clinical trial with the reference pertuzumab in previously untreated patients with HER2-positive metastatic breast cancer on August 19, 2021. The study was titled, “Prospective, randomised, multi-centre, comparative, double-blind, parallel study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of test Pertuzumab.”

On review by the subject expert committee, the Indian regulatory agency, the Central Drug Standard Control Organisation (CDSCO), granted the approval on December 31, 2021. According to information accessed from ClinicalTrials.gov, the trial was initiated nine months later, that is, on September 17, 2022, and the estimated date of completion is set for December 31, 2024.

Curiously, Roche has raised the red flag, nearly 16 months after the imports were made. On questions about the logic and timing of raising such objections, Roche says it is in the process of collating and reviewing all the information.

Interestingly, Roche concedes it supplied Zydus with 480 vials of Perjeta in January last year. On why it honoured the order for such supplies even when it raised doubts on the quality of the reference products earlier, Roche spokesperson responded, “Whenever anyone has approached us for trials requirements or otherwise, Roche has never denied access to our innovations. Roche encourages the furthering of innovation and welcomes competition.”

It further adds to the important role of biosimilars in the sustainability of healthcare systems. At the same time, the company’s spokesperson added, “Roche strongly believes that all drugs in India, including biosimilars, should meet the highest standards of safety, efficacy, and quality in the interest of patients and enable healthcare professionals to make informed decisions.”

Biosimilars of expensive biotech drugs are emerging hopes for millions of patients in the developing world. For perspective, each vial of Perjeta by Roche is priced at Rs 2,75,000 in India. Any biosimilar of a blockbuster is typically launched in India at less than half or even lower, based on the number of players in the segment.

On inquiring whether it is illegal to procure drugs from the open market by any organisation for clinical trials or bioequivalence studies, the Roche spokesperson noted, “For any clinical trial of biosimilars, what is most critical is the authenticity of the referenced product that is used as trial samples because they are used as comparators to evaluate biosimilar products for patient safety and product efficacy.”

However, Roche strongly denied the possibility of pilferages in its global drug supply chain, indicating there may be spurious drugs that may be sold in the international market, some of which may have been brought into India.

  • Published On Jan 31, 2024 at 04:50 PM IST

Join the community of 2M+ industry professionals

Subscribe to our newsletter to get latest insights & analysis.

Download ETHealthworld App

  • Get Realtime updates
  • Save your favourite articles


Scan to download App


[ad_2]

Leave a Reply

Your email address will not be published. Required fields are marked *