•The most affected are especially those living in low-income countries and those from vulnerable populations
•A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents
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Many patients in low and middle-income countries including Kenya still lack access to generic and biosimilar drugs despite efforts to make them available.
A report released by Access to Medicine Foundation's Generic and Biosimilar Medicines Programme shows that despite their ability to serve as lifelines to millions of patients, generic and biosimilar products are still out of reach for many patients.
The most affected are especially those living in low-income countries and those from vulnerable populations.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents.
Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires.
The report comes from an analysis of efforts by five major companies to expand access to generic and biosimilar medicines in low- and middle-income countries (LMICs).
According to the report, even though the companies have a collectively broad regulatory footprint in LMICs, many essential products are not widely registered.
Similarly, they are using access strategies to expand access to their products in LMICs, yet efforts fall short for the poorest patients, adding that further efforts are needed to safeguard product availability.
The profiles of Cipla, Hikma, Sun Pharma, Teva, and Viatris were analysed in an effort to highlight opportunities to address gaps in affordable and reliable access to the quality-assured essential medicines produced by these companies.
The report says that even if a product is comparatively cheaper, those in need such as patients who rely on out-of-pocket expenditure for their healthcare may still not be able to afford it.
“When it comes to expanding access to medicine, the power of the generics industry is often underestimated. It’s more than the transactional relationship of selling drugs at volume and competing on price,” Access to Medicine Foundation CEO Jayasree K Iyer said.
Companies must engage with the unmet medical need globally for example by working with local manufacturers to improve supply, taking steps to safeguard quality and by addressing affordability for the poorest patients” K Iyer noted.
The report says that given their portfolios and footprints, the five companies can have a huge impact on access in LMICs, as can the wider generics industry.
The report identifies opportunities for each company to significantly enhance its impact and contribute to improving access to medicine in LMICs.
By acting on these opportunities, and by making access to medicine a priority, companies can ensure that their products reach the people who need them most no matter where they live.
“For the very first time, we're shining a spotlight on the actions, efforts, and commitments of leading generic and biosimilar medicine manufacturers to broaden access to lifesaving medicines in LMICs,” Claudia Martínez said.
“Although there are standout examples of action, clear opportunities also exist for companies to ramp up their efforts and to work closely with local implementers, governments, and global health organisations to continue to break down barriers for the millions who either lack adequate access or are forced to go without the medicines they need,” Martínez added,
Martínez is the Research Programme Manager, of the Generic and Biosimilar Medicines Programme.
Of the medicines classed as “essential” by the World Health Organization (WHO), 90 per cent are off-patent, including treatments for cancers, heart disease, epilepsy, diabetes, maternal haemorrhage, bacterial infection, tuberculosis, malaria and HIV.
Once a patent for a medicine expires, other drug manufacturers are free to develop a generic or biosimilar version and enter the market, potentially introducing competition and increasing supply.
Not only do generics and biosimilars offer the same therapeutic and clinical benefits as the originator medicines, but they are often supplied at a much lower cost.
Some of these companies now also manufacture generic or biosimilar versions of patented products under voluntary licensing agreements, which can expand and accelerate access to innovative medicines worldwide.