What is a Biobetter?
An article published by the Center for Biosimilars used a new word to the specialty pharmacy lexicon…… BioBetter….. prompting us to say “What’s that?”
Biobetter is not a common term in the United States but, perhaps, the term needs to be added to the US Pharma lexicon!
A good example is a recent FDA approval of sub-q Zymfentra (infliximab-dyyb) a reference product to Inflectra which was approved as an infused therapy in 2016. We will cover this approval later this week.
So WHAT?
The WHAT is that the FDA determined Zymfentra to be a novel drug because it allows for subcutaneous (vs. IV) administration. It was awarded its own unique NDA.
The article from the Centers for Biosimilars explains why the term BIOBETTER should be in common use in the US…… it is now used routinely in Europe. The idea being that we are very likely to see a big uptick in new drug approvals of therapies resulting from intentionally altering an existing biologic product to improve clinical outcomes.
Examples of meaningful differences include….. allowing for more time between doses or enhanced tolerability compared with the reference product. “Other examples of biobetters now include;
Susvimo (based on Lucentis [ranibizumab), Kadcyla (based on Herceptin [trastuzumab), Gazva (based on Rituxan [rituximab), and Neulasta Onpro (based on Neulasta [pegfilgrastim).”
So, are you ready to include Biobetters into your vocabulary?
