India tweaks biosimilar guidelines to narrow waivers in clinical trials


India has tweaked its draft of biosimilar approval guidelines and narrowed the scope to issue waivers required to run Phase III trials and rely on clinical references to biologic drugs not marketed yet in the country.

Under the purview of the Drug Controller General of India (DCGI), the Central Drugs Standard Control Organization, which worked with the country's Department of Biotechnology, released a draft in March that invited comments until April 30 on the scope of the guidelines.

The new release apparently took the comments to heart and made changes that keep the ability of regulators to waive comparative safety and efficacy studies, but in fewer situations than the earlier document in what it called “exceptional cases.”


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In May, Roche ($RHBBY) stepped up efforts to block approvals of copies of Avastin (bevacizumab) and other drugs labeled as biosimilars in India, pressing an advantage from a recent court ruling on Herceptin (trastuzumab) related to labels that cited work done by the originator.

Still, two firms--Reliance Life Sciences and Hetero Drugs--have launched biosimilars of bevacizumab in the past month that had been approved by the DCGI, though label changes were reportedly made.

But possibly in response to the Roche legal challenge, the new guidelines widened pharmacokinetic and pharmacodynamics criteria and noted confirmatory safety and efficacy studies are mandatory for mAb products.

The CDSCO had earlier noted that the guidelines do not replace existing rules under the Drugs & Cosmetics Act or any other relevant acts.

The government of Prime Minister Narendra Modi has been working for nearly two years to revise the 1940 law but has struggled to get the legislation through parliamentary committee as it grapples with evolving technological advances in drugs and devices.

India has also worked in the past year to refine informed consent procedures for clinical trials. The country has also raised the issue of the sequence of Phase III work for biologics in the guidelines to conform to the current practices.

- here are the revised guidelines

Related Articles:
India's Hetero launches Avastin biosimilar, following Reliance into the market
India to start fresh on pharma oversight by reworking 75-year-old law
India releases guidelines on biosimilar approval, manufacturing
Roche presses on biosimilar labels in India with Avastin challenge


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