Roche Requests DCGI to Check Gaps in the Clinical Trial of Perjeta

Roche Requests DCGI to Check Gaps in the Clinical Trial of Perjeta

By, Admin 5 April 2024

Roche requests DCGI to probe critical gaps in the clinical trial of its breast cancer drug Perjeta conducted by Zydus

Overview

Terming it a matter of “patient safety”, Roche has requested the Drugs Controller General of India (DCGI), the country’s regulatory agency, to inquire into the alleged critical gaps in the clinical trial conducted by Zydus of a drug originally developed by Roche. 

Roche’s Allegations on Zydus

  • In the last couple of months, there were media reports where Swiss giant Roche had raised questions that Ahmedabad-based Zydus may have flouted rules while conducting its clinical trial for biosimilar pertuzumab. 
  • The reports indicated that the reference drug used by Zydus in the starting phase of the clinical trial was procured from unauthorized sources (not an appointed/authorized distributor of Roche India or any other Roche Affiliate), and hence, might be of “questionable quality”, “compromised” or “spurious”.

 
Global biotech giant Roche has claimed that Zydus imported several vials of Perjeta from Germany during August and September 2022, outside of Roche's official supply chain. 

Response from Zydus

  • In response to these allegations, Zydus has vehemently denied any wrongdoing, dismissing the claims as baseless and unfounded. 
  • Zydus has asserted its adherence to regulatory standards and its commitment to ensuring the safety and efficacy of its clinical trial processes.

Recent Info

  • Recently, some more information has come to light. Pharmabiz has accessed certain documents that indicate that Zydus may have tried to circumvent existing processes in a hurry to tap the lucrative breast cancer market by launching their biosimilar without requisite approvals. 
  • Zydus seems to have received a Purchase Order (PO), issued on 19 April 2023, from Ripple Pharma, an entity in Nairobi, Kenya, for supplying 60,000 vials of pertuzumab 420 mg injection, while the clinical trial was underway. 
  • However, the Kenyan market presents a different scenario. No pertuzumab biosimilar has been registered in Kenya through its Pharmacy and Poisons Board. 
  • This is a requirement for any company to import and market the product in a legal and authorized manner. 
  • Pertuzumab is not listed in the Kenya Ministry of Health and the oncology priority list of the national supply agency KEMSA.
  • If the Kenyan government were to procure pertuzumab, the Ministry of Health would have to float a public tender through KEMSA and this has not yet happened. 
  • The volume of 60,000 vials of pertuzumab 420 mg seems exaggerated as compared to sales of existing breast cancer drugs like herceptin in Kenya. 

Other Queries

Sources further clarified that the above points raise several questions: 

  • Is the PO genuine and meant for supplying to the Kenyan market, where the drug is not approved nor is there a demand for it? or 
  • is the intent different? Possibly to direct the stock to the Indian market, as and when approval is received.  
  • Why was there a hurry when the product was still under clinical trial and had not been approved? 
  • Can such a product be trusted for quality and efficacy?

 On scanning the publicly available information related to this clinical trial by Zydus, fresh information has emerged related to the claims of unauthorized sourcing of the reference product, similar to the ones mentioned in earlier media reports.

Zydus Approval

  • Zydus received the approval to conduct its Pertuzumab clinical trial in November 2021. On January 11, 2022, Cadila/Zydus imported 497 vials of Perjeta through Amsterdam Pharma, which is not an appointed/authorized distributor of Roche India or any other Roche Affiliate. 
  • On 23 May 2022, Cadila/Zydus exported 497 vials of Perjeta to Yeni Dogu (not an authorized distributor of Roche), a company based in Turkey. 
  • This raises many questions: Were the 497 vials of Perjeta, imported from Amsterdam Pharma in January 2022, exported to Yeni Dogu? Why were the vials (supposedly imported in January 2022) exported/returned in May 2022? How were these vials stored for the intervening 5 months? Why were the vials not exported (returned) to Amsterdam Pharma?
  •  

Earlier, media reports had cited that Zydus had imported about 500 vials of Perjeta in August 2022 and September 2022 through Celtis Pharma (not an appointed/authorized distributor of Roche). Were the vials exported by Zydus to Yeni Dogu in May 2022 re-routed to India through Celtis Pharma?
 
Moreover, in January 2023, Zydus ordered 478 vials of Perjeta through Roche Pharma India. Why did Zydus not import this batch of Perjeta vials from Celtis Pharma or any other entity to complete the trials?

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