On October 30, Novartis announced that it was culling its investigational drug pipeline and dropping 20% of its development programs. Just three days later, its subsidiary Sandoz announced that it would halt its efforts to obtain approval for its biosimilar version of rituximab from the US Food and Drug Administration (FDA). The decision by Sandoz to halt its rituximab biosimilar filing efforts seems to have culminated from Novartis’ announcement and FDA actions.
Sandoz had received a complete response letter on May 2, 2018 in its attempt to obtain approval for use for Rituxan®’s oncologic (but not autoimmune) indications. According to Sandoz’s press release, the FDA had asked them for additional information before providing a new decision. Sandoz did not specify the type of data sought in the request, although the company’s Global Head of Biopharmaceuticals, Stefan Hedriks, hinted that additional studies were involved. He stated, “We appreciate the important conversations with the FDA, which have provided specific requirements for our potential US biosimilar rituximab, but believe the patient and marketplace needs in the US will be satisfied before we can generate the data required.” Generally, that means more than a re-analysis of existing data. This seems to be the principal reason for its decision to development and the rituximab biosimilar filing.
However, Rituxan is already available in several major markets, including Australia and New Zealand, the European Union, Japan, and Switzerland. Sandoz received US approval for three biosimilars, but only Zarxio® is currently marketed. Next up for Sandoz will be a refiling for FDA approval of its pegfilgrastim biosimilar. The company announced the original FDA rejection of this product in July 2016.
Amgen will have to wait a bit longer to market its biosimilar version of trastuzumab . On Friday, June 1, the Food and Drug Administration (FDA) rejected Amgen’s 351(k) application for its Herceptin® biosimilar. In a brief press release, Amgen announced receiving the complete response letter for ABP 980. In the announcement, it also said that the delay in its biosimilar trastuzumab approval should not “impact our US launch plan.” This may signal that even if it received approval, it would not market the biosimilar trastuzumab immediately.
The timing of the FDA announcement on the biosimilar trastuzumab approval contrasted with the near-simultaneous marketing authorization of this same trastuzumab biosimilar by the European Medicines Agency. The biologic will be marketed in Europe under the trade name Kanjinti™.
Mylan/Biocon’s Ogivri™ remains the only biosimilar trastuzumab approved by the FDA. It is not yet marketed, however. Separate trastuzumab biosimilars by Teva/Celltrion and Pfizer have been stalled by the FDA. Samsung Bioepis’s entry is due for an FDA approval decision in the fourth quarter of 2018.
In related biosimilar news… in September 2017, Mylan filed a 505(b)2 application for its insulin glargine agent. The manufacturing duo of Mylan and Biocon received a rejection from the FDA on June 1. The complete response letter specified issues raised by a change in manufacturing site (from one in India to a new facility in Malaysia). As reported by the Economic Times, the complete response letter was expected by Mylan and Biocon. They told the Economic Times, “Together, Mylan and Biocon are already executing on all required activities we had agreed upon with the FDA, and they are progressing according to plan,” the statement said.
Although insulins are not currently approved through the 351(k) biosimilar pathway, they are among the “transitional agents,” which by 2020 will be considered biosimilars by the FDA.