A roundup of the latest biosimilar news from The Center for Biosimilars®.
There has been a slew of recent biosimilars news: the steep discounted price of an interchangeable insulin glargine biosimilar, which has yet to launch; adherence rates for infliximab biosimilars and the originator product; a complete response letter (CRL) for a bevacizumab biosimilar; and an accepted biologics license application for a denosumab biosimilar.
Here is a roundup of the latest biosimilars news from The American Journal of Managed Care®’s sister site, The Center for Biosimilars®.
Insulin Biosimilar to Launch at 78% Discount
Eli Lilly and Company announced that it was going to significantly cut the prices of its insulin products and that it would launch Rezvoglar, its interchangeable insulin glargine biosimilar, at a 78% discount to the reference product, Lantus.
Rezvoglar was approved by the FDA in December 2021 as the second insulin glargine biosimilar to receive interchangeability. The biosimilar would be available as a 5-pack of KwikPens for $92.
Lilly also manufactures Humulin (recombinant human insulin) and Humalog (reference insulin lispro), as well as an unbranded insulin lispro product. In the fourth quarter of 2023, the prices of Humulin (100 u/mL) and Humalog (100 u/mL) will drop 70%. As of May 1, 2023, the price for the unbranded insulin lispro (100 u/mL) will be $25 per vial, making it the lowest list-priced mealtime insulin available.
Adherence to Infliximab Biosimilars vs Reference
Prevalent users of Remicade, the infliximab reference product, had the highest adherence rates compared with biosimilar users and naïve originator users. Researchers analyzed US claims data over 18 months of follow-up.
There are 3 infliximab biosimilars on the market in the United States. The study used claims data from 2015 to 2018 from the IBM Marketscan US commercial and Medicare databases. They identified patients who were infliximab-naïve biosimilar users (n = 96), infliximab-prevalent biosimilar users (n = 223), infliximab-naïve originator users (n = 2149), and infliximab-prevalent originator users (n = 10,970).
Optimal adherence was considered to be the proportion of days covered being more than 80%. Over time, across all 4 groups, the proportion of patients with optimal adherence decreased. Among prevalent originator users, 73% had optimal adherence at 12 months compared with 64% at 18 months. Biosimilar-naïve users had the lowest optimal adherence rate at 12 months at 43%; however, at 18 months, prevalent-biosimilar users had the lowest rate with 36%.
FDA Issues CRL for Bevacizumab Biosimilar
The FDA issued a CRL for a bevacizumab (Avastin) biosimilar from Biocon Biologics and Viatris, citing a failed manufacturing facility inspection as the cause of the CRL.
There were no issues with the preclinical and clinical trial results submitted as part of the BLA for the product, which is already available in Canada. In May 2022, the biosimilar launched in Canada under the name Abevmy. If it receives approval from the FDA, it will be the fifth bevacizumab biosimilar to be approved in the United States.
This CRL was the second one the companies received this year. The first one requested additional data to be submitted for their recombinant human insulin biosimilar.
BLA for Denosumab Biosimilar Accepted
The FDA will review the denosumab (Prolia/Xgeva) biosimilar GP2411 from Sandoz. Denosumab treats premenopausal patients with osteoporosis who are at an increased risk of fractures and patients with treatment-induced bone loss.
The BLA included data from ROSALIA, a phase 1/3 clinical trial, which demonstrated biosimilarity between the biosimilar and the reference product.
“In addition to being an important medicine for cancer of the bone, denosumab is critical in the treatment of osteoporosis and potential prevention of osteoporosis-related fractures that so many women over 50 are at risk of,” Keren Haruvi, president, Sandoz Inc and head of North America, said in a statement
The FDA is also reviewing a natalizumab biosimilar and a high-concentration version of the adalimumab biosimilar Hyrimoz, which is already approved in the low-concentration form.
There are currently no denosumab biosimilars approved in the United States.