Top of ANDA approvals list, low on IP index

In a sign of the times, 10 of the top 15 companies receiving the highest number of ANDA approvals in 2022 are Indian. An analysis of 2022 ANDA approvals shows that Indian companies once again dominated the ANDA approvals, with 355 or 48 per cent of total ANDA approvals. This further improves their share from 42 per cent (267 approvals) from last year, a 33 per cent growth of ANDA approvals for Indian companies versus 2021. India was followed by the US, China, Europe, and Israel, in that order, in the number of ANDA approvals.

The analysts, Meenu Grover Sharma, partner, Business Associar Consultants and Dr (Prof) Harvinder Popli, Director, School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences & Research University further point out that 42 per cent of first-time-generic approvals and 38 per cent of Competitive Generics Therapies (CGT) approvals were garnered by Indian companies. This was close to the score by US-based companies, which received about 50 per cent of all CGT approvals and 21 per cent of first-time-generic approvals.

The authors conclude that significant filing costs of almost a quarter million dollars per ANDA, increasing programme fees, and continuing pricing pressure with increasing competition have not dampened the interest in participating in the US generics space, especially for Indian players.

Moreover, over 11 per cent (86 of 742) ANDAs approved this year (including nine ANDAs approved through the CGT route) are already listed as discontinued, driven by the FDA guidance to notify significant disruption in availability or permanent discontinuation. Going by the trend observed in previous years, the authors estimate that if 18 per cent of this year’s ANDAs are discontinued by next year, it would represent approximately $32 million of sunk cost across all companies.

The question is, will companies look at reducing ANDA filings to curtail sunk costs? Or will the FOMO factor (fear-of-missing-out) continue to drive ANDA filings as a strategic competitive necessity?

The ANDA approvals also indicate that India, except for Biocon/Viatris, do not feature in biosimilar filings. Similarly, oral formulations dominate the ANDA filings from India (69 per cent of approvals) with little less than 20 per cent coming from injectables. The ratio is reversed for arch rival China (69 per cent injectable products and 26 per cent oral formulations.) These trends could represent missing links in India’s therapeutic offerings, which will need rectifying in the years ahead.

While India tops the list of ANDA approvals for the US market, it is near the other end of the US Chamber of Commerce’s International IP Index. Which is another sign of these times. India maintains a fairly low ranking of 42 out of 55 countries in 2023 International IP Index report, with the innovation score remaining unchanged from 2021 at 38.64 per cent.

The IP Index lists various weaknesses of India’s IP ecosystem, with the dissolution of the Intellectual Property Appellate Board in 2021, combined with the ‘long-standing issue of an under resourced and overstretched judiciary’, leading the list. India’s ‘limited framework for the protection of biopharmaceutical IP rights’, lack of regulatory data protection or patent term restoration for biopharmaceuticals and ‘lengthy pre-grant opposition proceedings’ are also cited. India’s first and only compulsory license granted way back in March 2012 for ‘commercial and nonemergency situations’ still figures as a weakness area as does ‘limited participation in international treaties.’

The IP index report does acknowledge some of the country’s areas of strength and measures deemed IP friendly, like ‘generous R&D and IP-based tax incentives’, and the fact that the country is a ‘global leader on targeted administrative incentives for the creation and use of IP assets for SMEs.’ It also mentions that there have been ‘strong awareness-raising efforts regarding the negative impact of piracy and counterfeiting.’

India’s dominance of ANDA approvals juxtaposed with the continued low ranking in the US Chamber of Commerce’s International IP Index signals that any tweaks in India’s IP regime will be for the country’s benefit and not overtly influenced by diplomatic and trade pressures. India will continue to forge its own IP policy.

Thus the country continues to be a very vocal advocate for the proposal to waive IP rights for COVID vaccines and diagnostics, not just COVID therapeutics. Conversely, the IP index cautions that these negotiations with the World Trade Organization (WTO) and World Health Organization (WHO) to waive IP rights ‘will undermine the innovation ecosystem that was pivotal to combatting COVID-19 and threaten the ability to respond effectively to the next major global public health threat.’ Balancing market expansion strategies with IP policy will remain a recurrent theme for India pharma for the foreseeable future.