Six other generic biologics have been approved under ANDAs, a major advantage of which is that no clinical trial data are required and products can be designated therapeutically equivalent to a brand.

With no viable, abbreviated regulatory route for obtaining market approval for most generic biologic drugs in the US, the Richmond, Virginia–based biotech's announcement in July that it had ...

and the regulatory pathway for generic biologics remains undefined. While these actions are not expected to eliminate frivolous citizen petitions or the marketing of authorized generic drugs in ...

His prescient investment in biosimilars, or generic biologic drugs, has given Sandoz more than 50% of the hot market, and will probably reverse a recent dip in sales growth. It's a gene thing ...

NEWARK, Del, Jan. 10, 2025 (GLOBE NEWSWIRE) -- The global biologics market is projected to witness substantial growth, with an estimated worth of USD 450.2 billion in 2025, reaching USD 1,077.2 ...

Generic injectables maker Gland Pharma on February 3 reported a 7% rise in third-quarter profit, as lower expenses helped ...

Alongside margin recovery, Biocon Biologics has also gained market share, with oncology remaining a key focus area.

Biocon's board has approved the acquisition of 1.5% equity in Biocon Biologics for Rs 550 crore, increasing its stake to 90.2 ...