FDA OKs Mylan’s biosimilar of Roche cancer drug Herceptin

Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision

The US Food and Drug Administration has approved Mylan’s biosimilar of Roche’s blockbuster treatment for breast cancer, Herceptin, making it the second copycat cancer drug to be approved in the US.

The FDA said Mylan’s drug Ogivri, which was co-developed with India’s Biocon, was the first biosimilar approved in the US to treat breast or stomach cancer.
Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision. Their similar versions are called biosimilars, instead of generics.

Herceptin is one of the world’s most successful antibody drugs and has been a mainstay of Roche profits for many years.

Annual sales of Roche’s cancer medicines exceed $21 billion or over half its pharmaceuticals business sales but the drugs – Rituxan, Herceptin and Avastin – are coming under threat as their biosimilar versions get approval. The FDA in September approved Amgen’s biosimilar of Avastin.

The FDA approved Mylan’s Ogivri to treat certain types of breast and stomach cancers.

However, the launch of Ogivri is uncertain at this point, following a licensing agreement with Roche, Cantor Fitzgerald analyst Louise Chen wrote in a note to clients.

Mylan and Biocon reached a settlement and licensing agreement with Roche in March to launch the biosimilar in major markets. The terms of the deal and launch dates for the biosimilar in different markets were not disclosed, Mylan said.
Barclays analyst Douglas Tsao said although the drug is not expected to be launched until 2019, the approval adds credibility to Mylan’s biosimilar efforts.

Mylan and Biocon are also developing a biosimilar to Amgen’s drug Neulasta, which got a complete response letter (CRL) from the FDA in October, asking for more data related to their manufacturing facilities.