2015: year of the biosimilar

In March 2010, US President Barack Obama signed the Patient Protection and Affordable Care Act, also known as Obamacare, into law. It was preceded in 2009 by the Biologics Price Competition and Innovation Act (BPCIA), which introduced a shortened pathway for approving biosimilars, medicines that have been developed to be close to existing biologic drugs.

Last July, the US Food and Drug Administration (FDA) approved for review the US’s first biosimilar application—Sandoz’s Zarzio.

Zarzio is a follow-on version of Amgen’s drug Neupogen (filgrastim), which stimulates the growth of white blood cells in the body, and is used to treat patients who have low levels of white blood cells because of cancer, or have recently undergone a bone marrow transplant.

The US is fairly late to the biosimilars game. The European Medicines Agency approved its first biosimilar drug in 2006, and now there are more than 20 biosimilars available in the EU. In fact, Zarxio (as Zarzio is known in Europe) is the first biosimilar in the EU to overtake its reference product in terms of market share.

With many blockbuster biologics either soon to lose patent protection in the US or having already fallen over the patent cliff (Neupogen lost patent protection in the US in 2013), this year we’re likely to see many more applications with the FDA for biosimilar approval. What lessons can those applicants take from Zarzio’s approval process?

Zarzio

As it has already received marketing approval in more than 40 countries, creating a substantial amount of clinical data, Zarzio is ahead of the game in many ways.

“Zarzio is very lucky to have so much data,” says Patrice Jean, a partner at law firm Kenyon & Kenyon in New York.

“If there’s one lesson for biosimilar makers in countries that already have a lot of experimental data, it would be to get their ducks in a row and get their experimental data ready to use at the FDA so that they can get their products approved very quickly.”