Similar attitude will not work for 'Bio-Similars'- FDA

The Food and Drug Administration (FDA) of the United States has reworked on their thinking on biosimilar drugs recently, mentioning that due to their rigidity the “one size fits all” followed by them all these days will not work.

Instead, the agency’s scientists would weigh the array of information or the evidences in its entirety to judge the biosimilarity. According to the many chief FDA officials who have written in the Aug. 4 issue of the New England Journal of Medicine have designed a feasible approach to review and approval of biosimilars in the United States.

For several years now, Biotechnology and pharmaceutical companies have been noticing the decisions taken by the FDA very closely, as the market for biosimilars is claims to be really large. Talking local, the Momenta Pharmaceuticals Inc. of Cambridge has already entered into the development of biosimilars and Quintiles Transnational Corp., which is  based in North Carolina with offices in Cambridge, has already signed a deal of $266 million partnership with South Korea’s Samsung Group to produce biosimilars near the Seoul.

According to market studies, the world wide biosimilars market is expected to hit $19.4 billion by the year 2014 with a compound rate of 89.1 percent annual growth from 2009 to 2014. In the year 2008, Asia was the dominant market because it went into the commercialization of its products quite early. However, according to the researches conducted, the Americas will possibly in all likelihood dominate in 2014 triggered by U.S. market opening to the products in 2010.

After all this discussion, we must be clear about this thing called as ‘Biosimilars’. What is Biosimilars in the first place? Biosimilars are products that are similar to, (but not the same as), a new drug. Also known follow-on biologics, these products cost far less than an innovative drug. They treat patients who previously could not afford them with their new affordable treatment. These are not generic drugs that are considered to be the same as the brand. It is however official, but the journal article does signal towards the likelihood of its review applications for biosimilar products under the Biologics Price Competition and Innovation Act.

FDA and User Fee Act (for 2012)

Most of us know FDA is government body that regulates and monitors food and drug produced for commercial purpose. Its prime job is to evaluate safety of therapeutic products, be it food or medicine or cosmetic products. A question must have arisen in your mind, except those who are privy of internal matter, about where such a large agency gets fund to keep running. FDA is funded by two ways; one, money from tax payers; second, 'user fee' a fee paid by applicants.

There are two federal laws according to which FDA can take fee from manufacturers of drug or medical device. Every manufacturer has to acquire approval from FDA for their respective product. Producer can not bring their product in market without FDA approval.

PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act) are the two laws which authorize FDA to take fee. The fee is only for use in CDER and CBER i.e. Center for drug evaluation research and Center for biologic evaluation research. FDA has to propose amendment if it wants increment in fee. Last time PDUFA was amended in 2007. Reauthorization for the year 2012 is being contemplated and final bill is likely be tabled in January for vote by Congress.

The law set a sort of benchmark for FDA. At the time of New Drug Application (NDA), FDA should ensure speedy approval of the 90% their new applications in 6 to 10 months. FDA has to meet this benchmark if it wants to continue fee collection. This condition is matter of concern for a part of community. Some people believe that while fullfiling the assurity, safety might get compromised.

Women birth control pills