Again in Rough Waters?
Swiss multinational pharma giant Roche has raised the alarm over the clinical trials being conducted for a biosimilar of its widely used biologic drug for breast cancer, Perjeta in India. This comes close on the heels of the recent cough syrup-related controversy.
It has filed a complaint with the Drugs Controller General of India (DCGI) against Ahmedabad-based Zydus Lifesciences Ltd, which is conducting the trials. The nature of the complaint, filed in November 2023, pertains to the quality of the drug used for the trial. The drug used in the initial phase of trials has not been procured from the company as per Roche’ claim.
Hence, it may be of questionable quality, compromised and spurious, it has been alleged. It had also sought the credibility of the source of the drug procured in September 2022 and the information on supply chain norms. Once again, in February 2024, Roche sought the regulator’s intervention and probe on this issue in February 2024 since it is a matter of patient safety.
Zydus has denied the allegation as baseless, perceiving it as an attempt to malign its reputation and discredit it in making expensive drugs accessible at affordable prices in the domestic market. It said the company has been conducting trials and introducing novel biologics and biosimilars.
All necessary regulations and processes are followed regarding ethics and safety and it was committed to share with the regulator all the relevant information.
Zydus was conducting trials to test a biosimilar to Perjeta labelled ZRC-3277. It is for treating patients suffering from malignant neoplasm of the breast of unspecified size, referring to a type of cancerous growth in the breast. Clinical trials have to be conducted in comparison to a reference drug. In this case, the reference drug is Perjeta invented by Roche.
The trials received regulatory clearance from DCGI in December 2021. The company procured 500 vials of the drug Perjeta from Germany in August and September 2022 for clinical trials in India. But Roche claimed it was not procured from the company’s official supply chain. As per Roche’s records, Zydus procured 480 vials from Roche in January 2023. Hence, Roche has raised questions about how and from where Zydus accessed the drug for the initial part of the trials since the trials started in September 2022 and it procured the drug from Roche only in January 2023.
Going by the details of the nature of the allegations, the issue appears to have assumed the form of one’s claims against the other’s. While Roche’s concerns could be right, some Indian experts feel that one of the angles to the issue could be of MNC-domestic competition. Whatever may be the case, it should be addressed on a priority basis.
As experts perceive it, the issue is not very complicated. The regulator should resolve it expeditiously by seeking information from the Indian company on its procurement of drugs in September 2022 and matching it with Roche’s dealers. Delay in such matters may snowball into a controversy. Expeditious resolution and subsequent actions are required in such cases since the reputation of the Indian companies is at stake.
Roche has tried to block biosimilars of its drugs earlier too. In 2016, it filed a suit in the Delhi High Court against DCGI to block approval of any biosimilar of its other cancer drug Avastin. Before that, it blocked the launch of a biosimilar of another of its breast cancer drugs Herceptin. If the biosimilar sector is to be protected in the interest of patients, so that they get costly drugs at a lesser cost, the government will have to find out a long-term policy solution to the problem, which may be in the form of separate legislation.