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Philippines FDA approves world’s first generic version of Pfizer’s anti-Covid pill

Manila (Philippines), January 25: The Philippines Food and Drug Administration (FDA) has approved the world’s first generic version of Pfizer’s anti-Coronavirus pill Paxlovid, just days after the original was granted Emergency Use Authorisation (EUA) by the US FDA.

The Philippines FDA has approved the department of health’s application for a compassionate special permit application for the first generic version of Paxlovid that has been launched by Beximco Pharmaceuticals, a leading generic drugmaker from Bangladesh.

Philippines-based Pharmaceutical company Biocare Lifesciences Inc would be the distributor and importer of a generic drug, which would be sold under the brand name Bexovid in the Philippines.

According to Pfizer, the risk of hospitalisation or death is reduced by 89% when Paxlovid is given within three days of the onset of symptoms and by 88% when given within five days of the onset of symptoms. The treatment, a combination of Nirmatrelvir and Ritonavir tablets, is given together twice a day for five days and is recommended for treatment of mild to moderate cases of Covid-19.

Pfizer data also suggests the drug remains effective against the faster-spreading Omicron variant of the Coronavirus, which is driving the latest surge in Covid-19 cases globally.

“The approval by the Philippines FDA will make Bexovid accessible to Covid-19 patients in the country and add another treatment protocol to the existing drugs. We plan to import 20,000 to 30,000 courses of Bexovid initially and expect the supplies to begin in the first week of February. Bexovid is expected to be priced 50-60% cheaper than the original Pfizer drug, making it an affordable option,” said Dileep Tiwari, Managing Director, Biocare Lifesciences, during an interview with CNN.

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Bexovid is recommended as an at-home treatment to help reduce the severity of the infection. The drug has the potential to eliminate many hospitalizations, thus helping reduce the strain on the healthcare infrastructure.

“Bexovid is not meant for patients who are hospitalised. Any patient who is Covid-19 positive can buy the drug from hospitals once supplies begin,” said Mr. Tiwari in a CNN interview.

Separately, Bangladesh’s Directorate General of Drug Administration has also granted EUA for Bexovid to treat mild-to-moderate Covid-19 cases in patients aged 12 and above.