Health groups condemn HC order on breast cancer drug Herceptin

Health groups condemn HC order on breast cancer drug HerceptinPublic health activists have criticized the Delhi High Court's order that banned the sale of bio-similar versions of breast cancer drug Herceptin (Trastuzumab) till next hearing on appeal of Swiss drug maker Roche.

The Delhi High Court has ordered Bangalore-based Biocon and U. S. generic drug maker Mylan not to compare their versions of the breast cancer drug to drug innovator Roche's original cancer drug Herceptin, or use the brand name. But the main problem is that the generic drug makers can only market their bio-similar drugs by linking them to the original compound.

Campaign for Affordable Trastuzumab described the HC's order as "unwarranted & inexplicable," while Biocon described it as an "extremely shocking" development, adding that it was Swiss drug maker Roche's  attempt to protect its monopoly in India.

The patient-interest group said in a statement, "The court has also restrained Biocon from relying upon any data relating to Trastuzumab's manufacturing process, safety, efficacy and sales. This is contrary to the provisions of The Drugs and Cosmetics Act of India."

Roche has sued Biocon and Mylan as well as the Drug Controller General of India, alleging that the companies didn't aptly conducted the phase-I and phase-II clinical trials for the Trastuzumab drug.

The Swiss drug maker also accused Indian drug regulator of approving Biocon and Mylan's generic versions of breast cancer drug Trastuzumab without due diligence.