Mylan and Biocon Launch Biosimilar Trastuzumab, Ogivri, in the United States

Mylan and Biocon have announced that their biosimilar trastuzumab, Ogivri, has become commercially available in the United States. The biosimilar, referencing Herceptin, is now available in a 420-mg multidose vial and a 150-mg single-dose vial.

The drug makers did not specify the list price of the biosimilar, but said in a statement that the drug will have a “competitive discount” to its reference “to help ensure access and increase treatment options for patients.” Mylan will offer a full suite of patient services for Ogivri via its Mylan Advocate program, said the companies, and Biocon has sufficient manufacturing capacity to supply both the US market and global markets where the product has already begun to reach patients.

Christiane Hamacher, PhD, chief executive officer of Biocon Biologics, called today’s launch “an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multi-use vials and 150mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and [payers] in the US.”

Mylan’s president, Rajiv Malik, added that the biosimilar will “increase more affordable access to this important treatment option for breast and gastric cancer patients. With regulatory approval for our biosimilar trastuzumab in more than 80 countries worldwide, we are bringing vast global biosimilars experience to the US and look forward to continuing our work with all stakeholders in the healthcare system.”

Ogivri was the first biosimilar referencing Herceptin to be approved by the FDA, though it is second to launch, following Amgen’s Kanjinti in July of this year.

Approval of Ogivri was based in part on data from the phase 3 HERITAGE trial, a double-blind, randomized clinical trial that evaluated the biosimilar in patients with HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. In the study, the biosimilar proved to be equivalent to the reference in terms of overall response rate at week 24, and safety was also comparable. Postmarketing data from ex-US territories also support the safety profile of the product, underscoring consistency with the safety profile of the reference trastuzumab.

Ogivri is Mylan and Biocon’s second oncology biosimilar to launch in the United States; first was Fulphila, a pegfilgrastim biosimilar referencing Neulasta, which launched in July 2018 at a 33% discount to its reference.