Humira, a blockbuster treatment for rheumatoid arthritis is under the attack of many biosimilar players. After the recent patent extension of Enbrel (etanercept) in the USA, Humira and Remicade will lose more of their sales once the biosimilars for rheumatoid arthritis treatments reach the market worldwide.
In order to stop this attack, Abbott Laboratories has filed a citizen’s petition with the FDA, to ask the agency not to approve any biosimilars of Humira. The submission was made on April 2 was mainly based on “trade secrets”; Abbott says that FDA will have to use the company’s trade secrets to approve biosimilars in the USA.
“Under well-established Supreme Court jurisprudence, FDA’s use of the trade secrets in (Abbott’s) Biologics License Applications to support approval of competitor products would frustrate (its) investment-backed expectation regarding their property and would constitute a taking under the Fifth Amendment to the US Constitution that requires just compensation. FDA should not implement the BPCIA in any manner that would raise this constitutional issue,” Abbott writes in its 30-page petition.
The reason behind this move is logical from some points; Humira was submitted for approval prior to the enactment of the Biologic Price Competition and Innovation Act of 2009, which is incorporated into the Affordable Care Act that was signed into law in March 2010. But will this critical move be successful and stop Humira biosimilars in the USA?
We will all wait and see…
If you want to read the citizen’s petition, you can reach the full text here: