Ensuring access

How pharma companies compare in registering their products

On-patent product registration is a key step in medicine and vaccine access, but progress rates vary.

On-patent and off-patent/generic medicines registration varies
Viatris TB medicine pretomanid offers example of good practice

The Benchmark looks at whether the companies are registering the products in their portfolios in the 102 low and middle-income countries (LMICs) in scope, and in how many of these countries they have filed for registration.

The figures below show higher numbers of registrations for companies’ on-patent vaccine portfolios than for on-patent medicines, with Pfizer performing strongly in both categories.

FIGURE 1. Registration filings for on-patent medicines, by company. There are 17 on-patent antibacterials and antifungals covered by this analysis, marketed by seven companies. This figure shows the number of countries in scope in which each company has registered at least one of its products.

FIGURE 2. Registration filings for on-patent vaccines, by company. There are 18 antibacterial vaccines covered by this analysis, marketed by four companies. This figure shows the number of countries in scope in which each company has registered at least one of its products.

How the companies compare in registering their off-patent/generic medicines

The generic medicine manufacturers in scope have larger portfolios of off-patent/generic medicines that qualify for analysis than the large research-based companies.

However, large research-based companies file each of their off-patent medicines more widely (in 52 of the 102 LMICs, on average) compared to generic medicine manufacturers (34 on average).

Registration filings for off-patent/generic medicines, by company. There are 131 off-patent/generic medicines covered by this analysis, marketed by 16 companies. This figure shows the number of countries in scope in which each company has registered at least one of its products.

Good Practice

Viatris: TB medicine pretomanid

In 2020, Viatris newly filed its TB medicine pretomanid for registration in 23 of the LMICs in scope.

Pretomanid was developed by the TB Alliance and is approved by the FDA and the EMA for the treatment of extensively drug resistant TB (XDR-TB), as well as for treatment-intolerant/non-responsive multi-drug resistant TB (MDR-TB), as part of a six-month ‘BPaL’ oral treatment regimen that combines bedaquiline, pretomanid, and linezolid.

WHO recommendations for the use of pretomanid and the BPaL regimen currently apply only under operational research conditions. One of the countries where Viatris filed pretomanid for registration is India, a country with a high burden of TB.

The company took this step less than one year after receiving its initial FDA approval, demonstrating a focus on filing for registration across a wider range of countries.