- Contract manufacturer Lonza has agreed to produce some of the drug product needed to make Celltrion's biosimilar to Remicade, a blockbuster immunology medicine from Johnson & Johnson.
- The copycat drug, called Remsima outside the U.S., first received approval in Europe in 2013 as a treatment for a lengthy list of autoimmune diseases, including Crohn's, ulcerative colitis and rheumatoid arthritis. Three years later, it gained approval stateside, where Pfizer markets it under the brand name Inflectra.
- Under the new deal, Lonza will make Remsima drug substance at its commercial facility in Singapore to cover European and North American markets. Celltrion said the deal should "diversify its supply base and meet the increasing demands of the biosimilar market," in a Tuesday statement.
South Korea-based Celltrion has been growing, in large part due to its biopharmaceutical medicines business, which has ballooned to nearly 6 times the size of its chemical medicines business. Last year, the company recorded 982 billion South Korean won (around $820 million) in revenue, up 3.4% from 2017.
Celltrion's products include biosimilar versions of Remicade (infliximab) and Roche's Herceptin (trastuzumab) and Rituxan (rituximab).
While Remsima/Inflectra (infliximab-dyyb) is the only one of those three to have brought in substantial U.S. revenue, it still faces challenges. Global revenue from the drug was down 3% year over year to $153 million during the second quarter, as slightly greater penetration in certain channels was offset by larger pricing and competitive pressures.
Celltrion's partner Pfizer is adamant that Inflectra's stagnant U.S. performance is due to anticompetitive practices at J&J, and has even taken its big pharma peer to court over the issue.
"Unfortunately, adverse incentives that favor higher-cost originator biologics are keeping biosimilars from reaching patients," Pfizer CEO Albert Bourla said earlier this year.
"I can't think of a more concerning example of a broken U.S. healthcare system that is directly impacting the pocketbooks of Americans."
On its end, Celltrion is trying to shore up manufacturing capacity for its biosimilar business.
Last year, the Food and Drug Administration hit one of the company's two Korean production sites with a Complete Response Letter that detailed deficient aseptic practices and adequate investigations into complaints of an unknown substance in vials.
Celltrion said in the Sept. 3 statement that the Lonza deal complements its existing manufacturing capacity, which can create 190,000 liters of drug substance per year across the two Korean plants.
Lonza, meanwhile, has been reorganizing to put a greater focus on human pharmaceuticals — and biologics in particular.
"We will be working in close partnership with Celltrion to ensure it has access to the flexible capacity and agile teams it needs to respond to evolving market demand for Remsima," said Marc Funk, Lonza Group CEO.
"In the competitive biosimilars market, we can support Celltrion with our experience in biologics as it enables broader patient access to affordable, life-changing therapies," Funk added.