One Aflibercept Trial Begins; Another Insulin Recall

In recent biosimilar news, Alvotech hits a new milestone by commencing a phase 3 trial for its aflibercept biosimilar and Mylan is tasked with alerting wholesalers, retailers, and patients that a single batch of Viatris’ unbranded insulin glargine biosimilar has been recalled.

Alvotech Begins Dosage for Phase 3 Aflibercept Biosimilar Study

Iceland-based biosimilar manufacturer Alvotech initiated its phase 3 study (ALVOEYE) assessing the safety, efficacy, and immunogenicity profiles of its aflibercept biosimilar (AVT06) in patients with neovascular (wet) age-related macular degeneration (AMD).

The biosimilar references Eylea, which is one of the most widely-used drugs to treat several ophthalmic conditions, including wet AMD, macular edema, and diabetic retinopathy. In 2021, global sales for Eylea amounted to $10 billion.

ALVOEYE is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study that will compare the biosimilar candidate with the reference product in 444 patients around the group. The primary end point is change in best corrected visual acuity from baseline to week 8.

“The initiation of this patient study marks an important step in the development of our AVT06 biosimilar candidate and demonstrates Alvotech’s commitment to developing biosimilars addressing key therapeutic areas in order to improve the lives of people around the world,” said Joseph McClellan, chief scientific officer at Alvotech, in the company’s announcement of the study commencement.

The ophthalmology space is a new and growing clinical area for biosimilars, as many of the countries that have ophthalmology biosimilars only have 1 or 2 on the market. According to Sonia T. Oskouei, PharmD, MCMAS, DPLA, at Asembia’s Specialty Pharmacy Summit, the United States is anticipated to welcome at least 7 aflibercept biosimilars in the next few years. However, no biosimilar referencing Eylea has been approved by the FDA or the European Medicines Agency so far.

Mylan Recalls Insulin Glargine Pens for Third Time

Mylan Pharmaceuticals, a company owned by Viatris, announced a voluntary recall for a single batch of it insulin glargine prefilled pens (100 U/mL). The pens are packaged in cartons of and are distributed at the consumer level.

The company noted that the recall is not for the branded Semglee insulin glargine pens; that is is only for the unbranded insulin glargine-yfgn pens. Mylan said that the batch is being recalled due to a potential issue with missing labels on some pens.

More specifically, the recall applies to 3-mL prefilled pens from batch number BF21002895 that carry an August 2023 expiration date. The batch was manufactured by Biocon and was distributed by Mylan in the United States between April 4 and May 5, 2022.

To initiate the recall, Mylan notified distributors and retailers by letter and arranged for the return of all recalled pens. Wholesalers and retailers were instructed to examine their inventory, quarantine, and discontinue distribution of the recalled batch and to notify customers within 5 business days.

Consumers were instructed to contact Sedgwick Claims Management Services, a third party claims administrator working with Mylan, for a documentation packet and to return the product. If they had any questions, they were directed to contact Viatris Customer Relations by phone or email as well as health care professionals if they experienced any issues related to taking or using a recalled pen.

The recall marked the third recall for Viatris unbranded insulin glargine batch this year, with the first occurring in January 2022 and the second occurring in April 2022. All 3 have been related to labelling issues.