The injunction issued by a Dehli court this past week will not prevent Mylan and Biocon from selling their biosimilar versions of Herceptin. It will however prevent them from referring to their drugs as biosimilar versions of Herceptin. Mylan criticized the ex-parte proceedings orchestrated by Roche and indicated that they "were given no notice of these proceedings, nor were they given an opportunity to be heard in this matter." A sort of Indian kangaroo court I suppose. Mylan says it will continue to manufacture and market its drug, Hertraz.
For its part, Roche says it has taken this action to ensure the "safety and efficacy of the drugs, as bioequivalents of Herceptin. As the holder of the Herceptin trademark we have a duty to ensure that if a company claims its product is a biosimilar of or similar to our innovator product trastuzumab, that this really is the case." Roche is seeking clarification as to whether the two rival products actually met the criteria for biosimilarity.
Bicon says, "This proceeding is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more affordable trastuzumab." Biocon did not say whether it would still launch its product this month as previously planned.
Stay tuned for more BIO WARS. See Biopharma-reporter.com.
Posted by Bruce Lehr Feb 13th 2014.