Biosimilars Check-in: Label Error Led to Insulin Biosimilar Recall, Samsung Bioepis Acquisition Completed

Patients and other stakeholders received some biosimilar news, with a small recall for Mylan’s unbranded insulin glargine biosimilar and the completed full acquisition of Samsung Bioepis by Samsung Biologics.

Insulin Glargine Batch Recall

Mylan Pharmaceuticals, a subsidiary of Viatris, issued a voluntary recall for a singular batch of its insulin glargine biosimilar. The recall applies to unbranded 10-mL vials of insulin glargine-yfgn with a batch number of BF21002800.

The Pittsburgh, Pennsylvania–based company said the batch is being recalled because the label may be missing on some vials. The batch where the error may be present was manufactured by Biocon and was distributed by Mylan in the United States between December 9, 2021, and March 4, 2022, with an expiration date of August 2023.

The company stressed that the recall does not apply to the branded interchangeable version of the biosimilar (Semglee).

In a risk statement, Mylan explained its reason for the recall, saying, “For patients receiving treatment with more than one type of insulin (eg, both short- and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar), which could result in serious complications. To date, no adverse events related to this recall have been received for this product.”

Insulin glargine-yfgn is a long-acting human insulin analog indicated to help patients with type 1 or type 2 diabetes with glycemic control. The unbranded product was approved by the FDA in July 2021 as the first insulin glargine biosimilar in the United States. In November 2021, it was relaunched with the Semglee label as the first interchangeable biosimilar.

Patients with questions regarding the recall are welcome to contact Viatris Customer Relations through their phone number or customer service email address. Patients can also get in touch with their health care provider if they have experienced any issues that may be related to the drug product.

Samsung Biologics Completes Samsung Bioepis Acquisition

Samsung Biologics said that it has completed its full acquisition of Samsung Bioepis, following Biogen’s sale of its stake in the joint venture for $2.3 billion.

The first payment of $1.0 billion pursuant to the terms of the acquisition agreement has been received by Samsung Biologics, marking that Samsung Bioepis is not a wholly owned subsidiary of Samsung Biologics. The remaining $1.3 billion will be paid through installments over the next 2 years.

According to a statement from Biogen, the company will continue to work with Samsung Bioepis on its exclusive agreements for the commercialization of 4 biosimilars: Benepali/Eticovo (etanercept-ykro), Flixabi/Renflexis (infliximab-abda), Imraldi/Hadlima (adalimumab-bwwd), and Byooviz (ranibizumab-nuna). Benepali references Enbrel (etanercept), Flixabi references Remicade (infliximab), Imraldi references Humira (adalimumab), and Byooviz is a biosimilar for Lucentis (ranibizumab).

John Rim, the CEO of Samsung Biologics, said the “announcement marks a significant milestone for Samsung Biologics in [their] continued venture into the biosimilar business and accelerating biosimilar growth.”

“By leveraging our extensive experience as a leading [contract development and manufacturing organization], we will further contribute to saving lives of the patients and address a wide array of diseases,” he continued.

In addition, Samsung Biologics is working to build Plant 4, which is expected to be completed in October 2022, and is in the process of securing additional land for the 350,000 sq m Bio Campus II, which will increase the companies capacity by 30% to allow for future growth.

“The acquisition gives Samsung Bioepis improved autonomy and agility in business operations, accelerating sales growth, operating margin improvements, as well as biosimilar development capabilities and future performance in novel drug development,” said Samsung Bioepis in a statement.