The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected to be followed by a European Commission final decision early in 2021.
Biocon Biologics, of Bangalore, India, and Mylan, of Canonsburg, Pennsylvania, have received a positive recommendation from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) for the marketing approval of their biosimilar insulin aspart candidate (Kixelle), a rapid-acting insulin for the treatment of type 1 and type 2 diabetes.
CHMP recommendations are a significant factor in final authorization for medicinal products from the European Commission (EC). Biocon and Mylan said they anticipate a final EC decision early in 2021.
Kixelle was recommended for marketing approval in injectable form (100 units/mL). Insulin aspart is fast-acting because it is absorbed more rapidly by the body and can act faster than human insulin. Like human insulin, aspart improves uptake of glucose into skeletal muscle and fat tissue and inhibits glucose output from the liver, according to the CHMP recommendation.
The biosimilar candidate references the originator brand insulin aspart NovoRapid, which was approved for EU distribution in September 1999. CHMP said data show that Kixelle has equivalent safety and efficacy. The product is recommended for adults, adolescents, and children older than 1 year.
“We are extremely pleased to receive a positive opinion…for our biosimilar Insulin aspart, co-developed with Mylan. This is an endorsement of the quality of our product and the data generated during its development,” said Christiane Hamacher, CEO of Biocon.
Although there are no insulin biosimilars approved on the US market, there are multiple insulin biosimilars available in Europe. These include insulin glargine, insulin lispro, and insulin aspart versions. For example, an insulin glargine marketed by Eli Lilly received marketing authorization in 2014.
In June 2020, Biocon and Mylan received FDA approval to market the insulin glargine product Semglee (referencing Lantus) in the United States, and this was launched in late August 2020; however, it was not approved under the Biologics Price Competition and Innovation Act and is not technically a biosimilar. It was approved under the 505(b)(2) New Drug Application pathway for generic medicines. Biocon and Mylan said they intend to improve Semglee's marketability by seeking biosimilar status for the product.
The March 2020 transition for biologics under the Biologics Price Competition and Innovation Act was designed to help break the near-monopoly held by a handful of innovator insulin products (Humalog, Eli Lilly; NovoLog, Novo Nordisk; Lantus, Sanofi) in the United States and allow biosimilar insulins to emerge and lower insulin prices. Heavy pressure by health care advocates, meanwhile, has brought about a lowering of co-pays and out-of-pocket costs for insulin products, improving access to these vital medicines.
According to a recent report by Amerisource Bergen, there are several types of insulin biosimilars in the development pipeline for the US market. Participating companies include Biocon/Mylan, Diasome, and Gan & Lee/Sandoz.