The FDA defines a biosimilar as "a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency."
Increased availability of biosimilars in the United States will result in significant patient savings and greater accessibility to important biologic medicine. The Affordable Care Act included a provision that created a pathway for the approval of biosimilars. In February 2012, the FDA issued guidelines for industry regarding implementation of the Biologics Price Competition and Innovation Act (BPCI Act) approval process.
Because the regulatory landscape for biosimilars is still evolving, ambiguity exists. Recent debate surrounds the naming policy for biosimilar drugs. Mainly, should these biosimilar drugs should be given the same nonproprietary names as original biologics? BPCI is seemingly silent in regards to the nomenclature FDA should apply to biosimilars -- and yet, the industry is abuzz with debate.
In a presentation at the World Health Organization's 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland, a compelling argument was made that biosimilar drugs should be given the same nonproprietary names as original biologics to ensure patient access and safe prescribing.
Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira, argued the following:
• Europe has approved biosimilars with the same nonproprietary names as their reference biologics for more than six years in a system that has proved effective
• Biosimilars have been successfully tracked in the marketplace using their brand name, meaning a separate nonproprietary name isn't necessary for keeping track of biosimilars once they're on the market
• The U.S. Affordable Care Act (ACA), under which Congress gave the U.S. Food and Drug Administration (FDA) a pathway to approve biosimilars, didn't include any language requiring separate nonproprietary names for biosimilars
• Different nonproprietary names for a biologic and the biosimilar product modeled from it could create confusion among the clinicians who rely on international and local standards to fill prescriptions for patients, potentially resulting in safety and medication access issues
Somewhat surprisingly, more and more big pharma names are agreeing with this sentiment. Novartis states, “assigning different INNs to biosimilars would introduce unnecessary confusion into the healthcare system and could unintentionally communicate increased caution, unfounded risk or other regulatory reservations that are purely hypothetical.”
However, trade groups for brand-name drugmakers and biotechs (PhRMA and BIO, for example) are still lobbying the FDA to ensure that every biosimilar has a unique non-proprietary name that will distinguish the medicine from the original biologic. In their view, distinct names would lessen marketplace confusion and aid in patient safety.
In a recent press release, BIO states, "BIO strongly opposes naming products in a way that will create confusion for physicians and patients and will hinder effective pharmacovigilance. Use of the same nonproprietary name suggests something that is not true for biosimilars - that they are the same as the innovator drugs they reference. When ultimately approved by the FDA, biosimilars will be similar to, but not the same as, their respective reference products."
And yet, many suggest that the debate has little to do with patient safety and more to do with money. To quote Biotech blogger Bruce Lehr, "Needless to say, this is a business question. How can I best protect (PhRMA/BIO) or promote (GPHA) my drug's sales once the biosimilar has been approved?"
What do you think?
