the use of biosimilars will ramp up fairly quickly once approved unless and until a major safety issue is seen.
Even if a stray safety problem does occur every now and then, FoB’s will not be derailed. For instance, JNJ’s Eprex, which is essentially a biosimilar of AMGN’s Epogen, had a contamination problem a few years ago; once the problem was solved, sales resumed with little or no lasting impact.
Any biologic drug can incur contamination in its manufacturing, and FoB’s are not less safe than other biologics simply because they are FoB’s. To the contrary, MNTA’s technology may allow its own FoB’s to meet a higher standard of purity than the corresponding branded drugs the FoB’s are based on.