Lotus Pharmaceutical Co Ltd (美時化學製藥) has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for lenalidomide, the company said in a statement on Friday.
The ANDA approval is for 2.5mg, 5mg, 10mg, 20mg and 25mg capsules of lenalidomide, which is a generic version of blood cancer drug Revlimid developed by Celgene Corp. It is the first product fully developed and manufactured in Lotus’ facilities in Taiwan.
Lotus expects to launch the product in the US — based on its patent litigation settlement with Celgene last year — some time after March 2022.
Under the settlement, Lotus is licensed to make and sell “certain volume-limited amounts of generic lenalidomide in the United States,” the statement said.
The volume-limited shipments would periodically increase by no more than a single-digit percentage until Jan. 31, 2026, it said.
Unlike new drug applications, an ANDA submitted to the FDA for review of a generic drug does not need preclinical and clinical trial data to establish safety and effectiveness.
The company has submitted new drug applications for lenalidomide in 81 countries. Twenty-three countries have approved it, including the US’ tentative approval, Lotus said.
“We are so excited to achieve another important milestone for our leading oncology portfolio — after obtaining approval of lenalidomide in Europe as the first generic,” chief executive officer Petar Vazharov said in the statement.
“We are now also among the first to receive an approval in the US, which solidifies Lotus’ core competence as the global preferred partner in oral oncology,” Vazharov said.
“We have successfully launched the product in selected European countries in February 2019 and we are confident that we will continue to deliver with our evolving portfolio,” he added.
Celgene’s blockbuster Revlimid reported global sales of about US$10 billion and US sales of US$7.3 billion last year, according to the Summit, New Jersey-based company.
Lotus posted net income of NT$298.62 million (US$10.2 million) in the second quarter, compared with NT$48.46 million in the same period last year. That translated into earnings per share (EPS) of NT$1.23, up from NT$0.2 a year earlier.
Net income in the first half of the year totaled NT$430.13 million, with EPS of NT$1.77.
The company’s cumulative revenue in the first eight months of the year totaled NT$6.58 billion, up 20.68 percent from a year earlier, company data showed.
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