Bangladesh Produces First Generic of Pfizer’s Antiviral But Indian Company Hits Snag with its Merck Generic
Antimicrobial Resistance 11/01/2022 •
Bexlovid, the world’s first generic of the successful Pfizer antiviral, is already on sale in Bangladesh.

The first generic version of Paxlovid, the Pfizer pill that has proven highly effective in treating COVID-19, is already available in Bangladesh.

However, Indian generic company Dr Reddy’s, which has started to produce the Merck antiviral, molnupiravir, might be in trouble after the country’s National Task Force for COVID-19 resolved on Monday that there were too many safety risks associated with the drug for it to be included in national treatment protocols, according to the Times of India.

Molunpiravir, which has been shown to reduce hospitalisations by 30% in clinical trials, has also been associated with birth defects and other issues.

However, Bangladesh’s generic company Beximco started distributing its version of Paxlovid – called Bexlovid – last week after Bangladesh’s Directorate General of Drug Administration issued an Emergency Use Authorisation (EUA) for its production on 30 December.

A week earlier, the US Food and Drug Administration (FDA) had issued an EUA for Paxlovid, allowing doctors to prescribe a five-day course for adults and children 12 years of age upwards within five days of symptoms for people who “are at high risk for progression to severe COVID-19, including hospitalization or death”. This includes people with obesity, diabetes and those over the age of 60.

The antiviral is a combination of two drugs – nirmatrelvir and ritonavir – and has been found 89% effective in preventing at-risk people with mild to moderate COVID-19 infections from severe disease and death.

“Having previously introduced the world’s first generic COVID-19 treatments of remdesivir and molnupiravir, we are pleased to add this breakthrough therapy to our portfolio,” said Beximco managing director Nazmul Hassan.

“It is further testament to our commitment to making affordable treatments accessible as soon as possible. As data continues to emerge demonstrating the effectiveness of nirmatrelvir and ritonavir against the the fast-emerging Omicron variant, we believe that Bexovid has the potential to be a powerful tool in combating the ongoing pandemic.”

Nirmatrelvir inhibits a SARS-CoV-2 enzyme to stop the virus from replicating, while ritonavir slows nirmatrelvir’s breakdown to help it remain in the body longer. 

Voluntary licenses for Pfizer pill

Last November, Pfizer signed a voluntary license agreement with the Medicines Patent Pool (MPP), enabling the MPP to grant sub-licenses to qualified generic medicine manufacturers, to produce and supply Paxlovid to 95 countries, covering up to approximately 53% of the world’s population. 

According to the agreement, Pfizer will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while COVID-19 is classified as a Public Health Emergency of International Concern by the World Health Organization (WHO).

Unlucky Dr Reddy’s?

After entering into a voluntary licensing agreement with Merck late last year, Indian generic company Dr Reddy’s announced this month that it will sell its generic version of Merck’s COVID antiviral, molnupiravir, for about $0.50 per capsule, or $20 for a five-day treatment course of 40 capsules – in comparison to Merck’s US price of around $700 per course.

But although India last week gave EUA to molnupiravir, the head of India’s Council of Medical Research, Dr Balram Bhargava, said that the drug had “major safety concerns” and would not be included in the country’s treatment protocols.

Meanwhile, wealthy nations have ordered around 30 million doses of Paxlovid, according to Luis Gil Abinader,, a researcher with Knowledge Ecology International (KEI), who has been tracking the orders. 

 

 

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