Delhi High Court had prevented Biocon from calling its breast cancer medicine Trastuzumab as a biosimilar of Roche's Herceptin.
Biotechnology firm Biocon on Tuesday said its product portfolio will not be affected by an order of the Delhi High Court that prevented the company from calling its breast cancer medicine Trastuzumab as a biosimilar of Roche's Herceptin.
"The High Court judgement does not restrict the sale and manufacture of Biocon's Trastuzumab, which is in the interest of patients...the current judgement will not affect our product portfolio," a Biocon spokesperson said in an emailed statement.
In an order following appeal by Roche, the court yesterday allowed Biocon and Mylan to continue to manufacture, market and advertise their products under the name CANMAb or Bmab-200 or Hertraz without calling them as bio similar or bio similar to Herceptin, Herclon and Biceltis.
Herceptin, a breast cancer treatment drug, is registered brand of Swiss pharma major Roche.
The Biocon spokesperson said: "We understand it has some observations with respect to packaging and labeling, which we will address appropriately. Our Trastuzumab, CANMAb has undergone all applicable comparability studies." When contacted, a Roche spokesperson said the "ruling sends a strong, positive signal that the development, manufacture and approval of biosimilars in India must be subject to rigorous clinical and regulatory standards as per the applicable law".
"The court has made clear that the approvals granted to these companies are not in accordance with the existing protocol for biosimilars and, therefore, their drugs cannot be considered biosimilars," the spokesperson added.
In 2013, Biocon had received approval from Indian drug regulator Drug Controller General of India (DCGI), to market what it then termed as 'biosimilar trastuzumab' developed jointly with Mylan for treating breast cancer.
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 "Delhi High Court had prevented Biocon from calling its breast cancer medicine Trastuzumab as a biosimilar of Roche's Herceptin.")
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