FDA approves Mylan's Ogivri as first biosimilar version of Roche's Herceptin

(Ref: The Wall Street Journal, Business Standard, Mylan, Nasdaq, FDA)

The FDA announced Friday the approval of Mylan's Ogivri (trastuzumab-dkst) as a biosimilar version of Roche's Herceptin (trastuzumab) for use in patients with HER2-positive breast and metastatic stomach cancers. The agency noted that the approval marks the first authorisation of a biosimilar for use in these indications. FDA Commissioner Scott Gottlieb remarked "the [agency] continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs." 

The approval comes after an FDA advisory panel unanimously backed approval of Ogivri for all eligible indications of Herceptin. The FDA noted that the submission of Ogivri, included results from the Phase III Heritage study, which demonstrated that the proposed biosimilar product, formerly known as MYL-1401O, is "highly similar" to Herceptin. 

For further analysis on the adoption of biosimilar cancer treatments, see Biosimilars in Oncology: KOL Insight.

Mylan jointly developed Ogivri with Biocon under the terms of a 2009 partnership. Meanwhile, Mylan reached an agreement with Roche earlier this year concerning patents covering Herceptin. 

Mylan noted that the drug remains under review by regulators in several markets including Europe. The biosimilar version was initially launched in India in 2014 following its approval by the Drugs Controller General of India in the preceding year. 

For related analysis on biosimilars, see also The Future of Biosimilars in the USA: Mapping critical uncertainties and the impact of future events