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Complex Generic Guidance by US FDA to benefit Indian Pharma Formulators: Ind-Ra


Ind-Ra believes that select Indian pharmaceutical formulators with pending ANDA approvals or developmental pipelines in these complex delivery systems would benefit from this development

India Ratings and Research (Ind-Ra) believes that increased guidance from the United States Food & Drug Administration (US FDA) on complex generics will provide increased clarity to US-focused Indian pharmaceutical formulators in preparing and submitting abbreviated new drug applications (ANDAs). This can reduce review cycles and expedite approvals. The current guidance dated October 9, 2018 is specific to complex transdermal and topical products.

Profitability Headwinds in the US: The agency in its Mid-Year FY19 Pharmaceutical Outlook had identified the lack of scientific and regulatory clarity about complex drugs as one of the key hurdles for approvals for complex products. Indian Pharmaceutical formulators have guided for low double-digit pricing erosion for their base portfolio at end-FY18 and are exiting highly generisied commercially unviable products and pruning R&D pipeline. In this scenario, a ramp-up in the less competitive complex generic portfolio is a sustainable solution to the reduction in economic pressures for US-focused pharmaceutical formulators.

Large Transdermal Opportunity: According to Ind-Ra’s analysis, the US transdermal market consists of 19 molecules across pain management, cardiology, gynaecology, gastro-intestinal, 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 player, the patents for five molecules have expired and balance have expiries over 2019-2020 and beyond. The transdermal molecules had a cumulative market size in the range of USD 3.5 billion-4.0 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 generisied. These three molecules have patent expires 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.

Lupin and Dr. Reddy’s Laboratories (IND AA+/Stable) are the only Indian players having a presence (one molecule each) in the generic transdermal space. Indian formulators such as Cadila Healthcare, Cipla (IND AAA/Stable) and Glenmark Pharmaceuticals (IND AA-/Stable) have ANDAs pending approvals in the topical space while Cadila Healthcare is the only Indian 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.

Guidance Required on Other Complex Generics: The pharmaceutical industry looks forward to the receipt of similar guidance on scientific, regulatory and legal issues for other complex generics as highlighted by US FDA 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 pharmaceutical formulators can therefore realign their R&D efforts to cut the time to market and benefit from subsequent product specific guidance.

Gearing up for Complex Generics: Indian pharmaceutical formulators have stepped up investments in R&D to ramp up presence in the complex generics space. Indian formulators such as Lupin (inhalation, injectable and ophthalmic), Cadila Healthcare (inhalation and injectable), Cipla (ophthalmic, injectable and inhalation), Torrent Pharmaceuticals Ltd (IND AA/Stable; injectable, dermatology and ophthalmic), Aurobindo Pharma Ltd. (IND AA+/RWP; ophthalmic and injectable) and Sun Pharmaceutical Industries Ltd. (dermatology, ophthalmic and oncology) are likely to be the key beneficiaries of emerging regulatory clarity over the near to medium term. 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, the ability of Indian formulators to compete/close the gap created by large established global peers in the complex generic space will remain critical.