Biosimilars in India News: Recent Guidelines from India’s CDSCO and a Pending Case on “Biosimilar” Trastuzumab

A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities.

In late March, India’s Central Drugs Standard Control Organization (CDSCO) published Proposed Revised Guidelines on Similar Biologics (2016), offering guidance on the regulatory requirements for biosimilars in India.

And a ruling last week by India’s High Court of Delhi may offer additional guidance on the requirements that must be met for drugs sold as “biosimilars.”   The Delhi High Court last week ruled that Biocon and Mylan could not label their versions of the breast cancer therapy drug trastuzumab as “biosimilars” of Roche’s Herceptin (sold in India under the brand names Herclon and Biceltis) because they did not meet the definition of “biosimilars” under India’s Drugs and Cosmetics Act (see media coverage here, here, and here).

The initial order, issued on April 25, restricted Biocon and Mylan from marketing their trastuzumab products (CANMAb and Hertraz, respectively), which had received regulatory approval in India in 2013; however, after the companies appealed the ruling, the court on April 28 allowed them to continue marketing their products until May 10, when the court will hold another hearing on the case.

As some have noted, this case will be closely watched for its potential impact on effective data exclusivity for reference biologic products, and labeling requirements for “biosimilars” and potential biosimilars in India.

Stay tuned to the Big Molecule Watch for further developments.