Regulatory Affairs

European Biosimilars Makers Weigh in on Latest Draft Guidelines

Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product, based on the actual amount of active ingredient in a dose, rather than a proposed standard that compares dosages and routes of administration. Read More

Apotex Sues Health Canada Over Import Ban

Generics maker Apotex has sued Health Canada over its ban of the company’s products from India, alleging the agency is enforcing the ban to blunt criticism against it by leaders in parliament and a national newspaper rather than in response to any legitimate quality manufacturing issues. Read More

Mallinckrodt Sues FDA Over Equivalence Change

Mallinckrodt has sued the FDA over its decision last month to revoke the equivalence rating on the company’s generic version of Janssen’s attention deficit hyperactivity disorder drug Concerta. Read More

Senate Subcommittee Probes Price Increases for Certain Generics

The recent spike in generic drug prices is not an isolated phenomenon, says a senator who introduced legislation last month that would require generics firms to provide a rebate to Medicaid if their prices rise faster than inflation, something that brandmakers already are required to do. Read More