Intro

Since 2019 patients and families affected by cystic fibrosis have been purchasing more affordable, generic versions of lifesaving CFTR (cystic fibrosis transmembrane conductance regulator) modulator treatments from Argentina. This briefing document sets out updated information for patients, families and carers, clinicians, and health officials who are interested in purchasing a new generic version of ETI (brand name Trikafta/Kaftrio) produced by generic manufacturer, Beximco Pharmaceuticals, in Bangladesh.

What is a buyers’ club?

Buyer’s clubs have played an important role in solving access to medicine challenges in many countries around the world over many years. The Hollywood film, Dallas Buyer’s Club, was a fictionalised account of the buyer’s clubs which sprung up in the 1980s and 90s in response to the lack of access to HIV treatment. It popularised the concept, but focused on medicines that had not yet secured proper regulatory authorisation following essential trials to prove efficacy.

However in recent years buyer’s clubs have been created in response to the pricing disparities that exist between originator, patented medicines, and quality-assured generic versions of the same medicine. The high prices of numerous patented medicines have resulted in millions of patients being denied access in countries across the globe. In the UK the NHS rationed access to the transformative, curative hepatitis C medicine, sofosbuvir due to the high price. It also fought a court battle to avoid responsibility for providing access to the HIV preventative medicine, PrEP, due to the anticipated cost. In both cases quality-assured generic versions of the drug were available in other countries for a small fraction of the price of the patented medicine.

Buyer’s clubs enable patients to understand their right to procure these more affordable versions of the drug, providing information that allows them to buy the medicine they need. In some cases they help patients to club together and secure a discounted price. This individual purchase right is translated into pooled demand to a generic manufacturer. They allow individual consumers to act collectively, and suppliers know in advance that they will get a collective volume of business if they respond to the group of consumers as if they were a single larger purchaser.

Many hundreds of UK patients have been cured of hepatitis C using generic versions of sofosbuvir bought through online buyer’s clubs, and thousands of UK citizens used generic PrEP to protect themselves from HIV with pills bought through buyer’s clubs.

Since 2019 cystic fibrosis patients from the UK and around the world, denied access to Vertex’s exorbitantly priced modulator treatments, have been utilising an informal buyers’ club established by the UK CF community to purchase and manage their condition with generic versions of these treatments.

What is ETI?

ETI stands for elexacaftor/tezacaftor/ivacaftor – a triple combination CF therapy that is sold by Vertex under the brand names Trikafta and Kaftrio. It is a highly efficacious medicine that dramatically extends the life expectancy, and improves the health of eligible CF patients. It was added to the WHO Essential Medicines List in September 2025 – a recognition of its importance. This increases pressure on national health systems to ensure sustainable and equitable access to it for CF patients.

As Vertex has used their monopoly powers to price Trikafta at up to $369,255 per patient per year, it is currently denied to thousands of CF patients across the world. Donation programmes initiated by Vertex in a small number of countries are a completely inadequate, opaque, and unsustainable means of ensuring long term access for all eligible CF patients worldwide. Affordable generic supplies have been essential to delivering sustainable global access to medicines for a range of conditions including HIV, hepatitis C, TB, and malaria. It is the only rational solution to the devastating inequity and injustice currently affecting the CF community.

Generic medicines, patents, and the law

When a new medicine is developed companies apply for a patent which gives them a 20 year monopoly to produce and market the product free from competition. Every country has its own laws pertaining to patents, but the World Trade Organization’s Trade Related aspects of Intellectual Property Rights (TRIPs) agreement sets out some global standards and protections. It also defines a number of flexibilities designed to ensure intellectual property rights are appropriately balanced with human rights, including the right to health. Patents are applied for, granted, and enforced at a national level, as are rules relating to the importation and use of medicines.

For a variety of reasons Vertex has not secured patents on its CFTR medicines in every country in the world, and so manufacturers in those countries are free to develop and sell generic versions of these drugs without infringing on their patents.

One flexibility in IP laws, commonly known as personal use exemptions, exists in many countries around the world. It enables patients or their family or carers to import and use generic versions of a medicine despite the existence of a patent in their home country. The rules and guidance differ from country to country but typically enable 3–12 months’ supply to be carried in luggage when travelling or shipped by post without infringing the intellectual property rights of the patent holder.

This means it is possible for buyers’ clubs to function, facilitating lifesaving access to affordable medicines, while fully respecting the law.

What is a generic medicine?

A generic medicine is a copy of a patented medicine, containing the same active pharmaceutical ingredients, and having the same effect on the patient. As it is not sold under a monopoly, multiple manufacturers can produce it and this leads to much lower prices as they compete with each other for sales. Use of generic medicines is incredibly widespread. On the NHS in England for example, 81% of medicines prescribed are generics.

Who is manufacturing generic ETI?

Initially, we were aware of two companies in Argentina, Gador and Tuteur, who were producing generic CFTRs.

However, in 2026, a new supplier entered the market, manufacturing a generic version of ETI, called Beximco Pharmaceuticals Ltd, based in Dhaka, Bangladesh.

Who are Beximco Pharmaceuticals?

Established in 1976, Beximco Pharmaceuticals is one of Bangladesh’s largest pharmaceutical companies, exporting to over 50 countries worldwide.

The company manufactures an extensive array of products – tablets, capsules, liquids, inhalers, sterile ophthalmics, injectables, prefilled syringes, oral films, IV fluids, etc. – from its main Dhaka site and a separate penicillin unit. It has a workforce of 5,700+ employees.

Adherence to a system of Good Manufacturing Practice (GMP) is the international gold standard for pharmaceutical quality and safety. GMP certification means a company’s facilities, processes, and controls meet strict regulatory requirements, ensuring:

• Medicines are safe, consistent, and effective
• Manufacturing sites are regularly inspected by authorities
• Medicines can be legally exported to countries that trust those regulators.

Beximco holds multiple GMP certifications from some of the most stringent regulators in the world, proving its reliability as a global manufacturer:

• Australia – TGA (2008): First Bangladeshi company to achieve GMP clearance, enabling exports to Australia and other countries.
• United States – US FDA (2015): Tongi oral solid dosage facility inspected; received an Establishment Inspection Report with no 483 observations, first ever US FDA approval for a Bangladeshi manufacturer.
• Brazil – ANVISA & Latin America: Certified by Brazil’s ANVISA and Colombia’s INVIMA.
• Gulf Countries (GCC): GMP approvals from UAE, Saudi Arabia, and other Gulf regulators.
• Canada – Health Canada (2014): First Bangladeshi company to obtain GMP approval.

Beximco was the first Bangladeshi company to export medicines to the USA. It was the first to launch a generic remdesivir for COVID-19 in May 2020. Beximco secured WHO Prequalification in 2019 for lamivudine (HIV antiretroviral), and approval for global procurement. The company holds multiple Medicines Patent Pool sub-licenses to produce affordable generics of sofosbuvir (Sovaldi), sofosbuvir and ledipasvir (Harvoni), sofosbuvir and velpatasvir (Epclusa), and daclatasvir (Daklinza).

How much does generic ETI cost?

Gador’s generic ETI – known as Trixicar – is priced at approximately $80,000 per patient per year, although costs have been changing frequently in significant part due to foreign exchange rate volatility.

Beximco is pricing their ETI – known as Triko – at $12,750 USD per adult per year. A paediatric/child dose will cost $6,375 per patient per year.

If clinicians oversee the implementation of a dose sparing strategy, combining ETI with clarithromycin, as pioneered by a CF team in South Africa, the cost of treating a child with cystic fibrosis drops to less than $2,000 per year.

This is around $368,000 less than Vertex’s US list price for Trikafta.

Is it safe and efficacious?

There are a number of mechanisms by which the safety and efficacy of generic medicines is ensured:

• Ensuring the ingredients in the medicine are comparable to the originator product. This can be demonstrated through in-vitro dissolution testing. Beximco have conducted these tests and the results show close alignment to Vertex’s reference product. These results have been included in the annex at the end of this document.
• Demonstrating comparable bio-equivalence of the generic and originator medicine in the body: Bio-equivalence testing of this nature is generally required to secure regulatory approval of a medicine in western health systems, particularly for drugs with the solubility profile of ETI. These tests are expensive and time consuming, but we are working with globally respected experts to design and implement bio-equivalence studies as soon as possible.
• Ensuring good manufacturing practice (GMP) at the factory production site: Beximco’s state of the art manufacturing facilities have been awarded certificates of GMP from stringent regulatory authorities around the world, and produce and supply medicines for multiple markets including the US and western Europe.
• Post-marketing studies and real world use: After a drug is being used within a clinical context doctors can monitor the impact on their patients. We hope that CF clinicians will be able to measure and share sweat-chloride, lung function, and other markers of CF patient health once they are using the generic product.

All medicines come with risks and side-effects. Indeed, the side effects experienced by cystic fibrosis patients taking Vertex’s products have been widely documented. We are working closely with pharmacists, regulatory experts, and clinicians to ensure we are putting in place all appropriate measures to minimise these risks and ensure generic ETI produced by Beximco meets regulatory standards and is quality-assured.

It is worth highlighting that the systems designed to ensure the safety and efficacy of medicines are wholly separate from the patent system, and patent protection is not a guarantee of quality.

When will bio-equivalence results be available?

We are working hard to design, fund, secure the relevant ethical and regulatory approvals, and undertake bioequivalence studies of the Beximco ETI.

In order to keep the price of the final product as low as possible we are working to cover the costs of these studies – estimated to cost at least $70,000 – from CF organisations and other philanthropic sources. Once funding is secured and all other necessary steps are followed, we expect to have BE results within a year.

We are very conscious that many CF patients cannot wait that long, and need access to ETI as soon as possible. That is why we are publicly confirming the existence of this affordable generic ETI now, with Beximco moving to initiate production as soon as possible. We do not believe we are best placed to make the risk-benefit calculations for every CF patient, some of whom may need to initiate treatment before BE testing has been completed.

If patients, their families or carers, and clinicians review the available information, and make an informed decision to prescribe and take the Beximco product then it will be available for purchase from Spring 2026.

I am interested – when can I buy it?

Beximco will begin shipping their ETI, Triko, in Spring 2026. Detailed information on the next steps, including how to place orders, will be available in the coming weeks.

How do I get it?

We are currently working with Beximco and a reputable global medicines distributor to establish a payment mechanism to allow for the purchase and supply of the medicine. We are also working with relevant CF associations and allies to explore the steps needed to simplify procurement and supply for every eligible patient.

Routes to access include:

• Supply to a national health system – this will require your government to move to overcome any patent or regulatory barriers to supply, and establish a mechanism to ensure access for patients. This is likely to lead to the most equitable and sustainable access for most patients. However it also requires the most effort by your health and other relevant authorities. This process would be greatly simplified if Vertex committed to standing aside, dropping any patent claims, and supporting the regulatory filing process needed.
• Consolidated supply for all or a group of CF patients in a country – it may be possible in some contexts for a national CF association or other body to pool demand and place a single order for multiple CF patients. This is likely to involve scoping and addressing any regulatory and legal barriers at a national level.
• Individual procurement under personal use exemptions – this is likely the means of supply that is most straightforward for most patients. Most countries have exemptions in patent laws to allow for the importation of medicines for personal or non-commercial use. But the rules differ from country to country, and some do not have this exemption in place.

In some countries it will be possible to legally buy and import up to six months supply of ETI by post or mail. In other countries it might only be possible to bring in the medicine in your baggage. This is the means by which most patients obtained the Gador generic product from Buenos Aries, Argentina. It will be possible to travel to Dhaka, Bangladesh to purchase generic ETI in person.

Some medicines delivered by post may be intercepted by customs and an import duty may be charged although in past experience from Buyers’ Clubs within the UK this is far from a consistent risk.

But please note, medicines may be seized and refunds are not guaranteed. It is important that you only import for yourself or someone in your care in accordance with the law. Resale of medicines is illegal in most countries.

It is important to review the guidelines in your country, consult with the relevant authorities, and make an informed decision on how you would like to proceed. We will provide detailed instructions on how to order, pay, and obtain the product via the various pathways.

Do I need my doctor’s support?

We encourage patients and their families or carers to discuss the option of procuring generic ETI with their clinician. This will simplify the process of securing the medicine, but will also help to ensure ongoing monitoring and support once on the treatment.

There is strong historic precedent for doctors supervising the use of generic medicines procured through Buyers’ Clubs in Europe, the US, Australia, and other countries. It would be helpful if you can get your CF doctor to provide a letter confirming your diagnosis and medical need, and a prescription for your treatment.

If your clinician is unable to provide a prescription, let us know – it should be possible to facilitate this from other supportive clinicians.

What is the dose reduction protocol?

Triko and Bexdeco – generic versions of Trikafta and Kalydeco – are a potentially life-changing treatment for cystic fibrosis patients with responsive mutations. Although much cheaper than Trikafta, cost and supply can still make access difficult.

The dose-sparing strategy, pioneered by a team in South Africa, makes Triko go much further by taking it alongside a strong CYP3A inhibitor such as clarithromycin.

Read our Triko Dose Sparing Guide →

I don’t know my genotype – what do I do?

Many countries and patients do not have easy access to genotyping tests to ensure their mutation is one which responds to ETI.

We are working with allied scientists and others to try to address this barrier to equitable access. If this situation applies to you, please get in touch info@CFbuyersclub.org.

It should be noted that studies conducted in France have demonstrated some level of efficacy of ETI among patients outside of the groups for whom ETI has regulatory approval, however this brings increased risk and uncertainty and should only be explored with full clinician support.

What do I do once I have my generic ETI?

Once you have taken possession of generic ETI, it is important to initiate treatment with the knowledge of your clinician.

Check the packaging, and take note of the batch number, and expiry date. Keep all documentation. Report side effects to your doctor and to your national medicines safety scheme.

We will be establishing a system to enable clinicians to share data showing how CF patients are responding to generic ETI. Please look out for information on that and encourage your clinician to share your test results anonymously.

What if I have other questions?

As we receive questions we will add them, and our answers, to our list of FAQs on the CF Buyers’ Club website. If your question has not been answered please contact us: info@CFBuyersClub.org.

Annex: in-vitro dissolution data

Quality parameters (in-vitro dissolution)

Ivacaftor 150 mg

Comparative dissolution of Reference Product (Kalydeco 150 mg Tablet) vs Test Product (Ivacaftor 150): Dissolution in 6.8 Phosphate Buffer with 0.7% SLS, 900 ml, 65 rpm, USP Type-II, Paddle, 37°C – Official media. Figures show dissolution (%).

Triple combination (Elexacaftor / Tezacaftor / Ivacaftor 75/50/100 mg)

Comparative dissolution of Reference Product (Kaftrio Tablet) vs Test Product (Ivacaftor + Tezacaftor + Elexacaftor 75/50/100 mg Tab): Dissolution in 1.8% Polysorbate 20 in 6.8 PB, 900 mL, 75 rpm, USP Type-II, Paddle, 37°C – Official media. Figures show dissolution (%).