Bangla generic drugs to the rescue

Cystic fibrosis is in the news again. Not because the rare disease is unknown or that there is no medicine to treat it but for a deal that a US patient help group has entered into with a drug company to secure generic versions of the staggeringly expensive medication to treat the genetic disorder. The real news is that the deal is not with an Indian company as one might expect; it is with a leading Bangladeshi generics manufacturer.  When the community-run buyer’s club was formed in Seattle in October to help patients around the world to access triko, the generic version of the life-saving Trikafta, a triple combination therapy developed by US drug giant Vertex Pharmaceuticals, it put the spotlight on Bangladesh’s pharma industry, which was set on a radical path of development in the aftermath of the country’s bloody secession from Pakistan in 1971.      

Triko has been developed by Beximco Pharmaceuticals and is expected to be available by the spring of 2026. This is great news for people who suffer from cystic fibrosis (CF), which progressively affects multiple organs, leading to serious respiratory issues and malnutrition. Delayed diagnosis and lack of treatment contribute to an average life expectancy of less than 20 years. The tragedy is that although medication is available, the triple combination therapy is simply unaffordable for the great majority of patients in low- and middle-income countries because of the staggering price. The tab for a year’s treatment with Trikafta comes to US $325,300. Beximco will offer it for $12,775 for an adult per year and $6,387.50 for a child per year. The Dhaka-based company is also separately launching BexDeco, a generic version of ivacaftor, one of the components of triko, at a fraction of its price. Beximco was approached by the patient community in the US to work on a more affordable generic version and it has come up trumps with a combination therapy 96 per cent cheaper than the original drug.

The uppermost question is why the buyer’s club—it was forged by CF patient groups with the support of multiple advocacy groups campaigning for access to life-saving drugs—entered into a tie-up with Beximco and not a company from the “pharmacy of the world” as India’s generic industry is known. The most obvious answer to this is that Beximco as a Bangladeshi company is exempt from the World Trade Organization’s (WTO’s) rules on intellectual property, known as TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) because Bangladesh is categorised as a least developed country (LDC). The exemption removed a major obstacle the development and production of the patented Trikafta. In other jurisdictions such as India, generic companies would have been entangled in patent battles because the blockbuster drug enjoys patent protection. And Vertex was bound to strongly challenge any patent infringement since Trikafta is the drug that brings in almost all of the Boston-headquartered company’s revenues. In 2024, it crossed $11.02 billion due to continued strong demand for Trikafta and its higher pricing. The CF Buyer’s Club believes the drug is one of the most profitable medicines in the world, with revenues of $29.5 billion generated in the 10 years from 2012 to 2021. But as of now, AbbVie’s Humira, an injectable drug to fight a range of inflammatory diseases, is the highest-selling pharma product in history, having earned nearly $200 billion till 2023 since its approval in 2002.

How will Beximco’s entry alter the outlook for Vertex and CF patients? As with most rare diseases, it is hard to come by reliable figures of the prevalence of the condition. According to the Journal of Cystic Fibrosis, an estimated 162,428-188,336 people are living with CF in 94 countries. Of these, just 65 per cent (105,352) have been diagnosed and even a small number, 19,516 or 12 per cent, receive the triple combination therapy. These estimates come with a caveat: CF statistics in low- and middle-income countries are not accurate owing to paucity of high-quality data. It is problematic in India, too, because there is no programme for screening new-born babies at the national level, although some states such as Goa are reported to be doing so. It is believed that CF is less common in India than in Western populations, ranging from approximately 10,000 to over 39,000. This implies that over 3,000 children are born with the condition each year. Since an increasing part of Vertex’s revenues are coming from its overseas sales, Beximco’s entry could turn the tide.

What is likely to change is the global perception of the Bangla pharma industry. It does not enjoy the high profile of India’s generics sector, but neither does it suffer from the negative image that its much bigger neighbour suffers from. There is a widespread perception that Indian generic manufacturers are too ready to enter into licensing arrangements with multinational drugs companies to safeguard their bottomline. The voluntary licensing favoured by drug majors allows generic companies to make their drugs under certain terms and conditions and it offers benefits to both. Although such licences specify where and how these drugs can be exported, it provides many an Indian company a safer alternative although some feisty firms, notably Natco Pharma, have not shied away from battle.

With Beximco making international news, it may spur policymakers to take a closer look at how Bangladesh refashioned its pharma sector to meet national health priorities after its breakup from the rest of Pakistan. Pharma journalist Vidya Krishnan, who has studied this closely, writes that Bangladesh is the only one of the 44 LDCs to have made good use of the trips flexibilities to foster a thriving pharma industry that manufactures medicines at the lowest priced in the world. But more important is its far superior regulatory regime which, Krishnan argues, has made the growth of its industry more orderly whereas the India suffers from “ineffective laws and a system of regulatory responsibilities divided almost incoherently between multiple national and state-level authorities”. This was most apparent when India’s toxic cough syrup killed children in The Gambia, Cameroon and Uzbekistan and more recently in Rajasthan and Madhya Pradesh. The government appears to be clueless about how these particular medicines were approved.

There is an opportunity here for both countries. We could learn to have a more effective regulation from our neighbour, while Bangladesh could take many tips from India on how to deal with a decidedly challenging situation when its LDC concessions end in 2026.