New USFDA Generic Guidelines to help Indian Pharma Companies in Submitting ANDAs

New Delhi: A weekend report by India Ratings has declared that the recent guidance from the US Food & Drug Administration (USFDA) on complex generics is expected to provide more clarity to US-focused Indian pharmaceutical formulators in preparing and submitting abbreviated new drug applications (ANDAs).

This will help domestic pharma formulators with pending ANDA approvals to reduce review cycles and expedite approvals, says a weekend report by India Ratings.

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.

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

According to Ind-Ra's analysis, the US transdermal market consists of 19 molecules across pain management, cardiology, gynaecology, gastrointestinal, neurology and anti-addiction.

Among these 10 molecules, there is no generic player, six molecules with one generic player and three molecules with four generic players.

Among the 10 molecules with no generic players, the patents for five molecules have expired and balance has expiries over 2019-2020 and beyond.

The transdermal molecules had a cumulative market size in the range of USD 3.5 billion-4 billion at end-2017.

Some of the large molecules in terms of market size include clonidine, estradiol, fentanyl and testosterone.

According to the analysis, the US complex topical patch market consists of four molecules across dermatology and pain management therapies.

Out of these, one molecule has two generic players (non-Indian) while the other three molecules have not been genericized.

These three molecules have patent expiring in April 2019, June 2021 and August 2027, respectively.

These molecules had a cumulative market size of around USD1.5 billion at end-2017 with lidocaine the largest molecule in terms of market size, it said.

Lupin and Dr Reddys Laboratories are the only Indian players having a presence with one molecule each in the generic transdermal space.

Indian formulators such as Cadila Healthcare, Cipla and Glenmark Pharmaceuticals have ANDAs pending approvals in the topical space while Cadila Healthcare is the only player with significant ANDA filings in the transdermal space and also has a dedicated manufacturing facility.

In FY17, Cadila Healthcare had also acquired one transdermal patch ANDA from Teva Pharmaceutical Industries.

The pharmaceutical industry now also looks 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 which 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, it added.

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