Roche has raised concerns over the clinical trials conducted by Indian drug maker Zydus Lifesciences on Perjeta, its popular breast cancer drug. The Swiss drug maker claims that 500 vials of the drug were sourced from questionable channels for trials in India. If the allegations are proven, it may spark a major controversy regarding the standards of clinical trials being followed in India.
Roche, the world’s largest oncology medication supplier, has questioned Zydus Lifesciences’ Perjeta (pertuzumab) clinical trials. The Swiss medication company claims 500 vials of the drug were obtained through dubious routes for Indian clinical trials.
If the central drug regulatory authorities investigate and substantiate the charges, it could spark a clinical trial scandal in India. After a period of low international pharma maker interest, clinical trials in India have increased.
According to Roche, Zydus imported German goods in August and September 2022 from outside its supply chain. The company claims that raises important questions about the reference products’ quality, supply chain requirements like safety and cold chain, and the credentials of the import supplier.
On August 19, 2021, Zydus submitted for approval to start a clinical trial using pertuzumab in previously untreated HER2-positive metastatic breast cancer patients, according to government statistics. It was called “Prospective, randomised, multi-centre, comparative, double-blind, parallel study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of test Pertuzumab.”
Following a topic expert committee examination, the Indian regulatory agency, CDSCO, approved the drug on December 31, 2021. ClinicalTrials.gov reports that the experiment began on September 17, 2022, and is expected to end on December 31, 2024.
Roche has expressed concerns nearly 16 months after the imports. Roche said it is gathering and assessing information on the logic and timing of such arguments.
Roche told Zydus it gave it 480 Perjeta vials in January. Roche spokeswoman said, “Whenever anyone has approached us for trials requirements or otherwise, Roche has never denied access to our innovations. Roche promotes innovation and competitiveness.
It reinforces biosimilars’ importance in healthcare system sustainability. The spokesman 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.”
Millions of developing world patients hope for biosimilars of pricey biotech medications. Perjeta by Roche costs Rs 2,75,000 per vial in India. Biosimilars of blockbusters are usually released in India at half or less, depending on the number of players.
When asked if it is illegal to procure drugs from the open market for clinical trials or bioequivalence studies, the Roche spokesperson said, “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.”
Roche firmly disputed pilferages in its global pharma supply chain, suggesting fake drugs may be sold internationally and transported into India.
Conclusion
Roche, the world’s largest oncology medicine vendor, has raised concerns over Zydus Lifesciences’ Perjeta breast cancer clinical trials. The Swiss medication company claims 500 vials of the drug were obtained through dubious routes for Indian clinical trials. If central drug regulatory authorities investigate and substantiate the charges, it could spark a clinical trial scandal in India.
The experiment began nine months later and is expected to end on December 31, 2024. Roche is evaluating all the data after raising the red flag approximately 16 months after the imports. The business believes that all Indian medications, including biosimilars, should meet the highest safety, effectiveness, and quality standards to benefit patients and help healthcare professionals make decisions.
