-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
CompilationTom Lee
A few days ago, Viatris said it was voluntarily recalling a batch of Semglee, an insulin glargine injection pen
.
The generic drug maker noted that the recall was announced because of possible missing labels on some of the Semglee pre-filled pens inside the label carton from a particular batch
Huizhi said the company has not received any reports of adverse events related to the recall
.
The batch in question was manufactured by Biocon and distributed in the U.
At present, Huizhi has not announced the specific number of injection pens involved in the recall
.
However, the company warns that the missing label on the Semglee prefilled pens could lead to the use of the wrong insulin in patients receiving more than one type of insulin, such as short-acting and long-acting insulin
It is worth noting that Huizhi specifically emphasized that the recalled products have nothing to do with its recently launched interchangeable biosimilars, the branded product Semglee injection or the unbranded product Insulin glargine injection
.
At present, the company has initiated a recall action for batch BF20003118, and has notified its distributors and retailers in writing, and is arranging the return of all recalled products, and informs consumers that if they find unlabeled products, they should call immediately.
On July 29 last year, the US FDA approved Huizhi's Semglee (generic insulin glargine-yfgn) as an exchangeable biosimilar of Sanofi's long-acting insulin Lantus, which is also the first FDA approval of an exchangeable biosimilar.
The first approved alternative biosimilar insulin for diabetes
.
In the first three quarters of last year, Lantus had global sales of 1.
However, at the end of last year, according to information on Huizhi’s official website, the U.
S.
Court of Appeals for the Federal Circuit extended the previous ruling of the U.
S.
Patent and Trademark Appeals Board and ruled that five patents for Sanofi’s best-selling Lantus insulin injection pen device were invalid
.
In a press release at the time, Huizhi said the decision reinforces Huizhi's ongoing efforts to break down barriers to patient access to important medicines such as Semglee
Huizhi was born in late 2020 as a result of the merger of the Mylan and Pfizer Upjohn divisions.
This packaging confusion is a serious concern in the pharmaceutical world, but a lack of labelling may not be the worst outcome
.
Last year, generic drug maker Meitheal Pharmaceuticals recalled a shipment of the muscle relaxant cisatracurium besylate due to an extremely dangerous packaging error after the company received complaints that the drug's carton was covered in Mislabeled phenylephrine hydrochloride, which is indicated for the treatment of hypotension
Reference source:
1.
2.
