Local pharma formulators to benefit from new USFDA generic guidance: Report

The recent guidance from the US-FDA on complex generics is expected to provide more clarity to US-focused Indian pharmaceutical formulators in preparing and submitting abbreviated new drug applications (ANDAs), a report by India Ratings (Ind-Ra) has said. This will help domestic pharma formulators with pending ANDA approvals to reduce review cycles and expedite approvals.

The current guidance dated October 9 is specific to complex transdermal and topical products.

The agency in its mid-year FY19 pharma outlook had identified the lack of scientific and regulatory clarity about complex drugs as one of the key hurdles for approvals of complex products.

Indian pharmaceutical formulators have indicated low double-digit pricing erosion for their base portfolio at end-FY18 and were exiting highly generic commercially unviable products and pruning R&D pipeline. The regulatory clarity will benefit formulators such as Lupin (inhalation, injectable and ophthalmic), Cadila Healthcare (inhalation and injectable), Cipla (ophthalmic, injectable and inhalation), Torrent Pharmaceuticals (injectable, dermatology and ophthalmic), Aurobindo Pharma (ophthalmic and injectable) and Sun Pharmaceutical Industries (dermatology, ophthalmic and oncology) over the near to medium term, the report noted.

In this scenario, a ramp-up in less competitive complex generic portfolio by stepping up investments is a sustainable solution, Ind-Ra noted.

According to Ind-Ra, the pharmaceutical industry will now also look forward to the receipt of similar guidance on scientific, regulatory and legal issues for other complex generics as highlighted by USFDA under the Drug Competition Action Plan. Other than transdermal, clarity is being sought by generic developers for other complex differentiated platforms such as liposomal/colloidal formulations, inhalational drug- device combinations like metered dosage inhaler, extended release injectable and ophthalmic products pending for approvals from the regulator or under development.

Indian formulators have also resorted to the acquisitions of products and technology platforms, to build niche capabilities that are at various stages of integration. However, their ability to compete/close the gap created by large established global peers in the complex generic space will remain critical, the report added.