Approval of biosimilars must be subject to rigorous clinical and regulatory standards.
The April 25, 2016 court order of the Single Judge of the Delhi High Court has made clear that the approvals granted to purported biosimilars of certain companies in India are not in accordance with the existing protocol for biosimilars and, therefore, their drugs cannot be considered biosimilars. This ruling sends a strong, positive signal that the development, manufacture and approval of biosimilars must be subject to rigorous clinical and regulatory standards.
We have taken this action because as the holder of the Herceptin trademark and innovator of Trastuzumab, we have a duty to ensure that if a company claims its product is a biosimilar of, or similar to our innovator product Trastuzumab, then it actually satisfies the criteria for a biosimilar. In order to ensure patients and physicians can make informed treatment decisions, it is critical that they have full access to information about products claiming to be similar to or a biosimilar of innovative biologics, and clarity on whether or not they have met the requirements for biosimilar products.
On April 27, the Division Bench refused to stay the order and has ordered that the status prevailing prior to April 25, 2016 will continue to operate. Despite these developments, the situation for patients and physicians remains unchanged as there is still no evidence that these products have met the requirements of the biosimilar framework or any other regulatory pathway in India.
The safety of patients will always remain a priority for Roche and we will continue to challenge companies that fail to present the data outlined in the Indian biosimilar framework. We will also continue to explore sustainable ways to bring effective and affordable healthcare to people and improve health outcomes.