UK regulators seize unlawful weight reduction medicine amid international pricing shake-up
UK drug regulators have shut down a bootleg manufacturing facility producing counterfeit glucagon-like peptide-1 receptor agonist (GLP1-RA) medicines within the East Midlands.
This follows a raid from the legislation enforcement unit of the Medicines and Healthcare merchandise Regulatory Company (MHRA), which seized 2,000 unlicensed weight reduction pens prepared for transport.
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The Northampton-based manufacturing website was producing counterfeit variations of Eli Lilly’s top-selling weight problems treatment, Zepbound (tirzepatide).
Unlicensed pens containing Eli Lilly’s investigational GLP-1RA, retatrutide, have been additionally discovered on the premises. The compound, which is presently in Section III trials for weight problems with comorbid knee osteoarthritis, has not acquired approval from any regulatory physique worldwide.
Alongside completed merchandise, “refined” manufacturing and packing gear was additionally discovered on the website, in addition to tens of 1000’s of autoinjectors able to be crammed.
In response to the MHRA, that is the most important single seizure of trafficked weight reduction medicines in recorded historical past.
International well being authorities warn towards counterfeit GLP-1RAs
Whereas that is the primary illicit manufacturing facility to be uncovered within the UK, each the MHRA and the European Medicines Company (EMA) have warned towards a surge in gross sales of unlawful GLP-1RAs, which the latter notes may “pose a critical danger to public well being”.
The US Meals and Drug Administration (FDA) has additionally picked up on this phenomenon, which led the company to introduce the ‘inexperienced checklist’, which flags out unlawful GLP-1RA compounders to curb the entry of such supplies to the US market.
This follows growing scrutiny round compounding pharmacies, which have beforehand been accused of promoting pretend variations of semaglutide.
Counterfeit medicine are additionally reaching sufferers by unlawful on-line pharmacies, which promote unregulated merchandise similar to GLP-1RAs. Many of those have been arrange throughout drug shortages, which have plagued the US healthcare system over the past decade.
Counterfeits achieve traction amid drug value surge
Demand for unlicensed and unapproved medicines could also be rising as sufferers grapple with sky-high drug costs. That is very true within the US, the place a month’s prescription of the top-selling weight reduction medicine, Zepbound and Novo Nordisk’s Wegovy (semaglutide), will set an uninsured affected person again $1,086.37 and $1,349, respectively.
The charges sufferers pay within the US are considerably greater than in different nations throughout Europe and Asia.
This drug pricing disparity has caught the eye of US President Donald Trump, who has made strikes to scale back branded drug costs by his Most Favored Nation (MFN) coverage.
Whereas the administration’s negotiations with the business are ongoing, Pfizer and AstraZeneca have already agreed offers with Trump, reducing the costs of sure medicines in change for a three-year exemption from 100% tariffs. Roche can be in talks with the US President over drug pricing reforms, in accordance with CEO Thomas Schinecker in a Q3 earnings name on 23 October.
Although this coverage is designed to focus on all drug courses, plainly Trump can even go after GLP-1RAs, as he inferred that he could be bringing the costs of “Ozempic, or the fat-loss drug,” right down to $150 to fall in step with prices of those medicines throughout Europe.
Regardless of Trump’s point out, which occurred at an Oval Workplace information convention to debate in vitro fertilisation (IVF) medicine, Medicare and Medicaid administrator Dr Mehmet Oz jumped in, stressing that this proposed value discount was not a achieved deal.
Whereas the validity of this assertion is unconfirmed, it nonetheless impacted each Novo Nordisk and Eli Lilly’s shares, leading to a 4% stoop for each firms.
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