This is the name of the article which was recently published in the New England Journal of Medicine. Officials from the U.S. FDA, have written the article and declared that, the approval for biosimilars “will require a new paradigm of sponsor-FDA interactions,” involving analysis of much more data than traditional generics.
Therefore hoping for a simple instruction manual with more clear goals and relatively low-cost data demands is impossible from FDA’s point of view. The regulations for developing biosimilars will come with its own complex set of customized instructions, complete with demands on animal and human data and new ground rules for initial talks with regulators.
As already known, the European biosimilar regulations established in 2005 as well as its own experience on abbreviated reviews for protein therapeutics, the regulators–a group which includes the head of FDA’s drug center, Janet Woodcock–say that: “given the complex nature of biologics, it’s unlikely that a ‘one size fits all’ systematic assessment of biosimilarity can be developed”.
“The FDA is currently considering how such interactions (with companies) might be structured and how they will affect the user-fee program that Congress has mandated for biosimilars,” the FDA said, referring to industry fees that drugmakers pay to help cover the costs of drug reviews.
The patent expiry dates for some blockbuster monoclonal antibodies are getting closer and many drugmakers await the market for biosimilars, including traditional generic manufacturers and other big pharma companies who have entered in biosimilars area in the recent years.
The market will range from relatively simple molecules like insulin to far more complex anti-cancer antibody medicines, growing to $3.7 billion by 2015 from just $243 million in 2010, according to a report from Datamonitor.
However, new technologies that can more accurately describe the unique “fingerprint” of a biotech medicine can help more easily compare it to a copycat version, FDA officials said. While fingerprinting wouldn’t eliminate the need for animal as well as human studies, those studies could be reduced in scope. And the FDA likes the EMA’s approach to monoclonal antibodies, with its emphasis on “populations, pharmacodynamic markers, and end points that are sensitive to the potential differences between products.”
Detailing on interchangeability, which would allow prescribers to switch an original biologic for a biosimilar, are still in the works but it is clear that FDA will be the decision maker for interchangeability in the US.
Additionally, despite the FDA’s efforts to develop guidelines, other U.S. regulations may discourage some biosimilar makers by giving more protection to branded biotech therapies. Under the U.S. healthcare law passed last year, brand-name biologic drugs were granted a 12-year period of market exclusivity before biosimilar versions can be sold.
It’s been over a year since the law passed and biosimilar regulations are still very much a work in progress at the FDA side. It should also be noted that, the FDA officials used the term “biosimilar” throughout the article, instead of the US-preferred term “follow-on biologics”.
The article can be found here: