Aducanumab has not been approved for generic selling? Yan Jian angrily sued.

On March 19th foreign media revealed that Biogen had sued Creative Biolabs, a Boston-based biotech company, for allegedly selling a ducanumab generic drug that was not approved for alzheimer's disease (AD).
if aducanumab succeeds in becoming the first approved New AD drug on the U.S. market in 15 years, it could theoretically generate billions of dollars in revenue.
but according to filings filed this week in federal court in Boston, Creative Biolabs has begun selling illegal generic versions of the experimental drug.
this behavior angered Biogen.
the first results of an external search for "aducanumab" (10:30 AM BST), Creative Biolabs describes itself as an antibody discovery and biopharmaceutical service company, advertising and offering an offer for the sale of aducanumab.
show on its website that a number of aducanumab products have been sold and, without legal rights, list "BIIB037" as an alternative name for that product.
", "the defendant intentionally infringes the intellectual property rights of Yan Jian and the University of Zurich and may cause irreparable harm to Yan Jian and the researchers who misused the defendant's unauthorized imitation products in scientific research and clinical studies." "Although Creative Biolabs claims to be the company that makes bioantibodies, its website confirms that it is making large copies of patented commercial products and products under development and is being sold on the site," said Mr. Yu.
"There may also be safety issues with generics, as Creative Biolabs is unlikely to use the same rigorous manufacturing control system as we do when making the drug, which could pose a public health hazard if confused with the clinical trials of YanJian aducanumab," said
.
" At present, Yan Jian is seeking to ban the sale of the drug, and the University of Zurich (which is granted a U.S. patent by Jian Jian) will initiate a lawsuit under U.S. federal patent and trademark law and Massachusetts law to stop Creative Labs Bio's illegal sale of its alleged innovative therapy, which is actually Yan Jian's aducanumab.
Aducanumab is a human monoclonal antibody that has been studied for the treatment of AD.
the drug was discovered by Neurimmune, who obtained a license for the drug and led the development.
the aumcorder targets the accumulation of beta-amyloid protein in the brains of AD patients in order to reduce this protein build-up.
, one of the drug companies that studied the "beta-amyloid plaque" hypothesis, was found to have poor results in almost all late-stage trials.
in fact, big biotech companies abandoned the drug about a year ago.
March 2019, Yan Jian released preliminary mid-term analysis data from two global Phase 3 clinical studies, ENGAGE and EMERGE, indicating that aducanumab was unable to reach the primary endpoint and halted the development of the drug.
later data mining found that a significant improvement was seen in the ad of adinaud a group of patients treated with high doses of aducanumab.
October 2019, Yan Jian announced the resumption of the FDA regulatory approval process for the innovative antibody, which is expected to be submitted for listing in early 2020, based on Phase 1/1b clinical studies data and a complete data set of two Phase 3 clinical studies.
December 2019, Yan Jian released detailed analysis data from EMERGE and ENGAGE, and during the 78-week observation time of the EMERGE trial, patients receiving high doses of aducanumab reached the primary endpoint, with a 23% reduction in the score of the Clinical Dementia Assessment Scale (CDR-SB) at 72 weeks of treatment.
in addition, the secondary endpoint mental status scale (MMSE) score decreased by 15%, and the cognitive weight scale (ADAS-Cog 13) and the Daily Life Power Scale (ADCS-ADL-MCI) score decreased by 27% and 40% respectively, proving that patients experienced significant improvements in cognition and function (such as memory, direction, and language) and also benefited from daily activities.
at the same time, there was a decrease in the biomarkers of Tau protein pathology and neurodegenerative lesions in the patient's cerebrospinal fluid.
Source: Sharon Cohen, a clinician who participated in the trial, believes that secondary endpoint ADCS-ADL-MCI is an indicator of a more clinically relevant impact.
notable, the incidence of high-dose drug-derived cerebral edema (ARIA-E) in the EMERGE and ENGAGE trials was 34% and 35.5%, respectively, with the incidence of ApoE-4 alleles being more than 40%. the importance of
ARIA-H is that it is closely associated with high amyloid load, even with patient mortality.
it is understood that He is still in follow-up contact with patients who have not yet completed the study.
the first quarter of the year, it is expected that Yan Jian will soon submit a Biological Products License Application (BLA) to the FDA.
some analysts believe that despite the overall poor clinical data for Phase 3, the FDA is still "nodding". Another problem that
is now facing is that with the COVID-19 pandemic, the timing of drug approvals and reviews is no longer predictable.
Source: 1, Biogen sues over 'Brazenly' daducanumab drug 2, Sauas pounce as Biogen details s s adcanumab - and both sides are digging in.