Indian companies shift focus to specialty drugs

Indian pharmaceutical companies focusing on US generics are building specialty generics pipelines. Price erosion due to increased competition in the USA has hastened Indian drug firms' push towards specialty medicines. The complexity being tapped is the active pharmaceutical ingredient (API) or formulation routes of delivery, a complex dosage form, or where the approval pathway has changed, reports The Pharma Letter’s India correspondent.

With the US Food and Drug Administration improving the approval process, approvals have been quicker, leading to increased competition in less complex generics. Competition has led to steep price erosion and has reduced the economic viability of some products.

Given the erosion of generic drugs prices in the USA, Indian generic drug manufacturers are exiting certain drug portfolios and are focusing on developing differentiated specialty generics, including biosimilars.