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Biosimilar FDA Roundup: June 2020


As the coronavirus disease 2019 pandemic continues to hinder the forward momentum for biosimilar approvals, FDA has shown that biosimilars are still a priority for the agency.

The coronavirus disease 2019 (COVID-19) pandemic had diverted FDA’s attention away from biosimilars and toward finding a reliable treatment and vaccine for general public. However, June brought the first US biosimilar approval of 2020 and the first biologic insulin, showing FDA’s continued commitment to advancing biosimilars.

FDA Regulatory Advancements

The first FDA approval for a biosimilar in 2020 was for Pfizer’s pegfilgrastim product (Nyvepria). Nyvepria is the fourth biosimilar referencing Amgen’s Neulasta to be approved in the United States. Pfizer plans to launch Nyvepria later this year on the US market but has not released an exact date.

Pegfilgrastim is used in patients with non-myeloid malignancies to lower the risks of infections caused by febrile neutropenia, a condition that can develop as a result of myelosuppressive anticancer drugs.

Around the same time, FDA approved a new insulin glargine product (Semglee) developed by Mylan and Biocon, which received an automatic status as a biologic under the rule change for the Biologics Price Competition and Innovation Act (BPCIA) that went into effect in late March, despite Semglee having been filed as a new drug application (NDA).

Mylan and Biocon said they intend to seek interchangeable status for Semglee, which would allow for the product to be switched with reference Lantus at the pharmacy level without seeking approval from a physician.

There also seems to be hope for another insulin glargine biosimilar developed by Lannett after the company received positive feedback on the pending biologics license application (BLA) for the product at the Biosimilar Biological Product Development Type II meeting held on June 9.

Additionally, Mylan, in collaboration with Revance, has decided to move forward with filing an application for FDA approval for an onabotulinumtoxinA (Botox) biosimilar, which could potentially be the first Botox biosimilar.

FDA also approved Eli Lilly’s new formulation for insulin lispro (Lyumjev) used for blood sugar control in patients with type 1 and type 2 diabetes. It is an injectable designed for rapid absorption after meals.

In addition, Eli Lilly said that the insulin product would be made available to patients with or without commercial insurance for a maximum $35 copay for a monthly supply in accordance with the insulin-affordability program the company implemented in April.

FDA’s New User Fee Program

Despite the pandemic causing major issues in most aspects for the pharmaceutical industry, it did make the case for FDA to design a project to upgrade its system for assessing workplace capacity and user fee requirements from manufacturers that file drug applications.

Prior to COVID-19, FDA had difficulties with estimating its resource needs for biosimilar application reviews. As applications for review increased, user fees did not, making it very difficult for the agency to afford more staff to handle the workload.

As the month carried on, FDA officials reported in a public meeting that the new prediction methodology for calculating biosimilar fees will help rectify these issues and have reduced work commitments to ensure the agency will have enough biosimilar program funding to last through the end of the 2022 fiscal year.

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