Novo petitions FDA to require Victoza copies to go through clinical trials, pointing to complex manufacturing
admin 9th October 2017 Uncategorised 0With one drugmaker already trying to pry patent protection off of Novo Nordisk’s blockbuster Victoza before its 2022 expiration, the insulin specialist has taken new steps to deter copies. The Danish drugmaker has filed a citizen petition arguing Victoza’s manufacturing process is so complex that equivalence of a copy couldn’t be certain without clinical trials.
More: Novo petitions FDA to require Victoza copies to go through clinical trials, pointing to complex manufacturing
Source: fierce