>Could GTCB perhaps have failures garnering regulatory approval of drugs that have competing products already in the marketplace that are produced in bioreactors?<
Yes, they could—and they probably will at some point.
As with any company, GTC cannot expect to obtain regulatory approval for a drug without demonstrating safety and efficacy in clinical trials. A GTC’s “knockoff” of a protein drug produced in a standard bioreactor will not be viewed as a full-fledged generic but rather as biosimilar. Thus, GTC’s successes in commercializing biosimilar drugs will be only as good as its successes—and its partners’ successes—in running clinical trials that meet their required endpoints.
I humbly submit that you are a step ahead of the market in this line of thinking, however. While you are asking whether GTC will succeed in commercializing large-selling biosimilar drugs, the market does not yet appear to realize that GTC is even a player in the biosimilar arena.