Pharmaceutical Executive September 27, 2021
The stars finally may be aligned for Americans to gain greater access to alternative biotech therapies in the coming months. FDA recently approved important new biosimilars for market, updated guidance on follow-on development, and reached agreement with industry on an agenda for advancing biosimilar testing and production over the next five years. Of note will be access to first biosimilar to treat macular degeneration, providing an important alternative for patients experiencing serious vision impairment from this and related eye diseases.1 That advance follows FDA authorization in July of the first interchangeable biologic, a new treatment for diabetes that can be substituted for widely used Lantus insulin glargine (see Jill Wechsler’s previous reports here and here.)
The development of additional innovative...