Eli Lilly sues four GLP-1 telehealth startups to escalate war against imitation drugs
The FDA gave Compares a bounty period to defeat drug production after the shortage was over. Small pharmacies had to comply until February 18th, but large outsourcing facilities remained until March 19th (semaglutide conpurginers were ordered to halt mass production this spring.
While many combined pharmacies and telehealth providers have stopped producing and selling, others continue to offer tilzepatide products in add-on materials, unapproved doses, or in various forms. Oral version etc.. “We’re in the minority,” says Jayne Hornung, chief clinical officer at pharmaceutical analytics firm Mmit.
Hornung said the companies that continue to sell tilzepatide are hoping to claim that they are not selling simple copies of Lily’s patented drugs through vitamin additives and other adjustments. “They’re getting very creative,” she says.
Compound pharmacies are generally allowed for patients to create customized medications, even if there is no shortage, such as if they are allergic to certain ingredients or require a carefully adjusted dose. The heart of Lily’s argument is that when it comes to tilzepatide, the drug therapy offered by drug-based telehealth companies is not truly personalized because it is mass-produced and prescribed by many patients.
“There are several ways the formulation can adjust the medication to a patient, including adding side effects, additional concerns and other ingredients that help diagnose,” said Annie Lambert, pharmacist and clinical program manager at information services company Wolters Kluwer. “But we need good science and evidence behind the safety of combining those things.”
Mass-produced versions of existing drugs with additives had not been widely available until recently. This was previously producing compounded tilzepatide, a pharmaceutical pharmacist at Olympia’s complex, but it stopped after the shortage ended and no additives were included. “We saw it from time to time, but it wasn’t this size,” she says. “It wasn’t that popular until I joined the GLP-1.”
In the lawsuit against Mochi, Eli Lily argues that telehealth companies “add the patient’s dosage and prescription at least five times, adding corporate profits rather than doctors’ decisions and exuding change.”
They claim that these changes include the creation of two new formulations containing niacinamide additives and pyridoxine. Both claim that the B vitamin form has not been proven to be safe or effective when combined with tilzepatide. Mochi’s own comparse, Aequita Pharmacy, has created some of these products. In March, Washington state regulators ordered production Stopped with Aequita Pharmacycites safety violations related to GLP-1 drugs.
In another lawsuit filed in the same California court, Lily alleges that Fella & Delilah Health switched all patients from their complex tilzepatide products without adding additives to versions containing untested amino acid additives later last year.
The drug giant’s lawsuit against Henry Med, which provides oral and injectable GLP-1 drugs, accused clinical trials of “creating false impressions” of confirming the drug’s effectiveness.
Lily’s lawsuit against Willow Health Services alleges that the Texas-based telehealth company is mistakenly selling some of its products as “custom preparations” to patients who have added oral droplets GLP-1 drugs or a version of complex tilzepatide with niacinamide.
Some companies selling combined GLP-1 drugs are unlikely to halt without a fight. Compounded Trade Group submitted a series Litigation They claim to the FDA on behalf of their clients that the agency declared a shortage of GLP-1 early. Whether their legal efforts have been successful or not, if demand continues to increase, there is still a possibility that drugs may be scarce again. As New research We continue to point out additional medical uses for these drugs, but it can happen very often.
“There’s no lawsuit about that because pharmacies are always compound drugs and they don’t try to compete with pharmaceutical companies,” Lambert says. “This is very controversial because it costs a lot of money.”