A week after Eli Lilly won an FDA emergency authorization for its COVID-19 antibody, concerns over limited supplies are already popping up, and the company is bringing in an experienced manufacturing partner to help with the global scale-up.
Under a long-term deal with Samsung Biologics, the companies are set to "greatly accelerate the global supply" for Lilly's COVID-19 antibodies, Samsung Biologics said in a release. Lilly hopes to make up to 1 million doses this year and many more in 2021, Reuters reports.
The partners entered an initial manufacturing partnership back in May, and, since then, Samsung produced a first batch of active pharmaceutical ingredient despite having a hard time getting raw materials. The companies handled the tech transfer in less than three months, a result of routine interactions between experts at both drugmakers, Samsung Biologics said.
Lilly’s bamlanivimab scored an FDA emergency use authorization last week in mild-to-moderate COVID-19 patients who are at a high risk of progressing to severe disease. The FDA said the medicine isn’t authorized in hospitalized patients, and Lilly is advising infusion within 10 days of symptom onset.
Before the emergency nod, the company entered a supply deal with the U.S. government for 300,000 doses at $1,250 per dose. Still, the stock could last just one week based on current infection trends, Reuters reports. While the deal includes an option for more doses, experts told the news service they expect the med will become a commercial drug at some point.
Lilly, which ran into FDA trouble at one of its plants that makes the antibody, has already secured multiple partners in its manufacturing effort. To help with its scale-up, the company tapped Amgen in September and Fujifilm last month, with Fujifilm set to produce doses for distribution to low- and middle-income countries.
At one of its own plants, Lilly reported last month that the FDA found inadequate “control of computer systems” during an inspection last November. The company stressed the issue wasn’t tied to the COVID-19 therapy.
Meanwhile, doctors are working to determine which patients might benefit most from the treatment, including by considering a “composite score” of overall risk, one doctor told Reuters.
Payers are already seeing value in the medicine at its current price, analytics firm GlobalData reports. Since the drug has the potential to reduce hospital burden during a pandemic, the firm can see payers accepting the drug at its current cost of $1,250 per vial.