Swiss Pharma major, Roche has withdrawn its special leave petition against Delhi High Court’s March 3 decision. The Supreme Court bench dismissed the petitions as withdrawn and the notice is being circulated through the counsel of petitioners.
On March 2, Delhi High Court held that Biocon and Mylan can market drugs for all three stages in breast cancer i.e., early breast cancer, gastric cancer and metastatic cancer.
India does not recognize data exclusively but data provided by Roche can be relied upon by the drug regulators, while approving a biosimilar drug. Biosimilars are considered a little sensitive, complex and difficult to make than the general biological drug. Their market share is also lower than the genetic drug and it also costs less than innovator drug.
Delhi High Court told Roche that it cannot hang on to Trastuzumab, innovated by it , for the rest of its life after having enjoyed patent for so many years.
Roche had challenged the approval mechanism adopted by Drug Controller of India , in giving Biocon and Mylan approval for its biosimilar drug and this decision was given by single judge of the Delhi High Court. He allowed them to market their products without any reference given to Roche’s biosimilarity. The single judge bench order was modified by division bench of Justices Badar Durrez Ahmed and Sanjiv Sachdeva and allowed Biocon and Mylan to use their product insert for only metastatic breast cancer.
Roche has criticised the Delhi High courts judgement as it denies patients to the right to make informed decisions about the treatment of breast cancer. Also it does not follow the procedures and protocols needed for the tests for the drugs.
Roche’s withdrawn of its SLP from the Supreme Court could be a market strategy according to analysts. They cite not only the CCI’s decision to probe Roche’s claim , but Roche ‘s settlements with US drug company Mylan. , granting a company a license for biosimilar Herceptin.