Feldman and Schor explain that the patent dance is a complex process to determine which of a biologic manufacturer’s patents ...

Slashing drug imports could trigger widespread shortages, experts said, because of America’s dependence on Chinese- and Indian-made chemical ingredients, which form the critical building blocks of ...

In conclusion, the 2025 CDSCO draft guidelines represent a meaningful and commendable step toward global regulatory alignment in the oversight of biosimilars. The agency has embraced major global ...