Two days after Mr. Gottlieb announced his departure from the FDA within a month on March 5, he released an updated draft guidance on biologics naming policy, adding another accomplishment in the last month of his tenure.
The question at the core is how to market “generic versions” of biologics, aka biosimilars. Unlike generic versions of traditional drugs, which could achieve a very confident level of equivalence to their original forms, the difference between biosimilars and their originals are “theoretically” high.
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.
– FDA
The naming policy comes into play to assert that difference.
For interchangeable biosimilars, the agency will designate a proper name that combines the core name and a distinguishing suffix that is devoid of meaning and composed of 4 lowercase letters.
– FDA
It is another confirmation that, biosimilars will not provide the similar competition as generics [to traditional drugs].
Biosimilars can be seen as lower-priced branded drugs. And it will really need real-world experiences to tell the interchangeability and other considerations.
A new biosimilar approval could be seen as providing a new solution, instead of providing a less expensive version of the current solution, to patients.