Pfizer and Viatris use registration to expand availability of on-patent antibiotics in low- and middle-income countries

Antibacterial and antifungal medicines and vaccines are essential for treating and preventing infectious diseases. Yet millions of people live without reliable access to them or lack information to use them properly. When companies do not file to register new and on-patent medicines in countries in need, low availability can also increase the risk of resistance. Patients may purchase or be prescribed medicines that do not meet medical need or quality standards. 

Registration is an important step to ensure products are made available for sale, especially in countries with higher levels of disease and inequality. Companies can show a commitment to enter markets in need by filing for registration with local regulatory authorities as widely and rapidly as possible after a product is first approved. 

Which companies demonstrate best practice?

Pfizer and Viatris are the only companies to have expanded registration to on-patent antibiotics, submitting filings in additional low-and middle-income countries each for specific products. Since the last Benchmark, Pfizer has filed its reserve antibiotic ceftazidime/avibactam (Zavicefta™) in 18 further countries including three low-income countries (Ethiopia, Tanzania, and Uganda). When implementing its access strategy for antimicrobials, Pfizer takes account of factors relating to patient and provider needs, and the ability for products to be used in consistency with its stewardship principles. The antibiotic, approved in 2016, plays a key role in treating complicated intra-abdominal infections and hospital-acquired pneumonia, which can both be fatal. Zavicefta™ is now registered in a total of 20 of the 102 low- and middle-income countries in the Benchmark assessment, including Brazil and India. 

Viatris newly filed its anti-tuberculosis medicine pretomanid (Dovprela) for registration in 23 access countries including five low-income countries (Democratic Republic of Congo, Ethiopia, Mozambique, Tajikistan and Zimbabwe). Almost all countries where Viatris registered pretomanid since 2020 have tuberculosis burdens that the WHO judges to be among the world’s highest. The medicine was developed by the TB Alliance and was first approved by the FDA in 2019. It is used for difficult-to-treat tuberculosis (XDR-TB and treatment-intolerant/non-responsive MDR-TB). Significantly, Viatris filed rapidly (within 12 months of receiving its first approval) in India, which has one of the highest burdens of tuberculosis. 

Next Steps

Especially in the case of key antibiotics, the Benchmark expects companies to improve access through registration. Filing can help companies increase patient reach and cut inappropriate use of antibiotics. Market size, financial opportunities and unclear local regulatory requirements may prevent companies from filing a product for registration in a specific country: in response, certain initiatives (such as the WHO Collaborative Registration Procedure and The African Medicines Regulatory Harmonization programme) can provide companies with support for product registration. Having local or regional offices in low- and middle-income countries may facilitate companies in submitting registration dossiers.

Pfizer, which demonstrates best practice, intends to expand access further in additional countries. It could consider filing for registration in countries with high burdens of intra-abdominal infections, complicated infections of the urinary tract or lower respiratory tract infections. Viatris could expand registration of pretomanid by filing for registration in more access countries, in particular the countries with a high burden of MDR-TB identified by the WHO, where it has commercialisation rights.

Few online regulatory databases yet track the registration of medicines in smaller, lower income countries. While regulatory agencies in low-and middle-income countries may lack the capacity for building and updating such databases, companies can play a role by increasing transparency about where they file products for registration. For example, Johnson & Johnson is the only company in scope to publicly disclose where it filed its MDR-TB medicine (bedaquiline). Companies should keep expanding registration to the most countries and make commitments for future action.