Roche Withdraws SLP Against Biocon and Mylan's Trastuzumab Biosimilar

Roche has withdrawn its Special Leave Petition (SLP) filed in India’s Supreme Court against a March 3 High Court decision to allow Biocon and Mylan to use the Swiss drug maker’s product data for their trastuzumab biosimilar.

In its March decision, the Delhi High Court ruled that Biocon and Mylan could market their trastuzumab to treat metastatic breast cancer, early breast cancer, and metastatic gastric cancer. Previously, Biocon and Mylan marketed their product (sold under the names CANMAb and Hertraz) for metastatic breast cancer only. The ruling, based upon approvals for the drug that were granted by the Drugs Controller General of India (DCGI), also allowed Biocon and Mylan to use Roche’s product data in their own labeling.

In the March case, Roche argued, unsuccessfully, that use of its clinical efficacy and safety data constituted an attempt on Biocon and Mylan’s part to capitalize on the Swiss drug maker’s product without having to conduct their own clinical trials. The Court agreed with Biocon and Mylan that Roche’s labeling was both publicly available and unprotected under Indian law, which does not recognize data exclusivity.

In its SLP, Roche attempted to challenge the approval that the DCGI had granted to Biocon and Mylan for their biosimilar of its innovator trastuzumab (which it has marketed in India under the names Herceptin, Herclon, and Biceltis). Roche claimed that allowing the biosimilar’s package insert to utilize Roche’s data denied patients and providers the chance to make informed decisions about breast cancer treatment.

In explaining why Roche dropped its petition over its blockbuster drug, some analysts point to an ongoing probe into ostensible anticompetitive practices undertaken by Roche. India’s antitrust regulator, the Competition Commission of India, announced in April that it was launching a detailed investigation into Roche’s practices with respect to trastuzumab after Mylan and Biocon filed a petition alleging that the drug maker had tried to thwart competition for its drug by misleading medical professionals.

Others look to Mylan and Biocon’s settlement with Roche in a US litigation concerning trastuzumab. In the March settlement, Roche agreed to grant the biosimilar developers a global license—exclusive of Japan, Brazil, and Mexico—in exchange for dropping 2 US-based challenges to its patents for the drug.

Mylan and Biocon’s product, currently under consideration at the FDA under the name MYL-1401O, received a unanimous recommendation of approval from the FDA’s Oncologic Drugs Advisory Committee on July 13. Final US regulatory action on the drug is expected by its user fee date of September 3, 2017.