Amgen now has company as the second biosimilar competitor to Herceptin^® has launched. On December 2, 2019, Mylan and Biocon announced the availability of Ogivri in the United States.

A price for the new biosimilar was not announced, but it is assumed that they will need to meet or beat Amgen’s initial offering, which was 13% below the average sales price of Herceptin. Mylan and Biocon have a licensing agreement with Genentech; it is unknown as to whether Amgen’s launch in July 2019 prompted an earlier-than-expected launch for Mylan/Biocon.

Ogivri is available in single-use vials in doses of 150 mg and 420 mg.

This marks the second biosimilar launch for the partners, the first being their pegfilgrastim product Fulphila^® in 2018.

In other biosimilar news…The Food and Drug Administration released in November its long-awaited draft guidelines for approval of biosimilar insulin agents. March 1, 2020 is the date FDA set for transitioning insulin copies, among other products (e.g., growth hormone) to the 351(k) approval pathway. The guidelines outline a key update to the expected regulations. Studies proving immunogenicity characteristics of the biosimilar insulin agents will likely not be necessary, which should lower the cost of entry and entice some prospective manufacturers. In its justification, FDA asserted that if the analytical assessment requirements are met, there would be very little risk of immunogenicity caused by the new biosimilar insulin.