Since the launch of the first Remicade biosimilar in 2016, drug giants like Pfizer and Amgen have made their own contributions to the lucrative market. Now, one company is looking to round out its subcutaneous and IV analogues with a third, oral tablet formulation that patients can take at home.
South Korea's Celltrion has teamed up with U.K.-based drug delivery firm Intract Pharma to codevelop the world's first tablet version of infliximab, a biosimilar of Johnson & Johnson's immunology blockbuster Remicade. With intravenous and subcutaneous versions of the drug already under its belt, Celltrion hopes the tie-up will further secure its position in the Crohn's disease and ulcerative colitis fields.
Intract will be on the hook to develop and advance oral infliximab through the clinic for treatment of inflammatory bowel disease (IBD), while Celltrion supplies drug material to manufacture the tablets. Upon completion of a phase 2 study, Celltrion will take over clinical development and marketing.
Oral infliximab has already snared an OK from the U.K.'s drug regulator—the Medicines and Healthcare products Regulatory Agency—to skip past further research and a clinical safety study and proceed straight into phase 1/2b testing in IBD patients during the second half of 2021, the companies said in a release.
Marketed as Inflectra in the U.S., Celltrion's IV infliximab became the first approved biosimilar version of Johnson & Johnson's Remicade in 2016. The drug boasts nods in children and adults with Crohn's disease, adult patients with moderate to severe ulcerative colitis and various forms of arthritis.
Since then, a cadre of Remicade rivals have entered the fray. Just over a year after Inflectra's green light, Samsung got a thumbs up for its IV biosimilar Renflexis. In December of that year, pharma major Pfizer nabbed approval for its own Remicade biosim, Ixifi; and a year after that, Amgen snagged an OK for its infliximab-based biosimilar Avsola.
Still, Celltrion's infliximab tablet could corner the biologics market on convenience, the drugmaker thinks. With the partners banking on the drug's approval as the world's first orally-administered antibody targeting IBD, a green light could help change the way IBD patients seek treatment.
“We anticipate that the oral infliximab product ... will have an improved safety profile and will offer a less expensive biotherapeutic treatment for IBD," Intract CEO Bill Lindsay said in a statement. "We are hopeful that the product will address a large proportion of the IBD market, potentially replacing steroid and immune-suppressive drugs in addition to capturing a large share of the biologics market."
Another potential boon? Patients may be able to take Celltrion and Intract's infliximab tablets at home, thanks to improved room-temperature stability that would make the drug easier to distribute and store, the companies said. That could give Celltrion's new infliximab formula a big leg up on rival biosimilars, which require healthcare professionals to administer injections. For patients already hit with physically debilitating diseases, a convenient, home-use option for IBD treatment could be a game-changer.
Plus, it's not Celltrion's first attempt at a biosimilar boost this year. In January, the South Korean drugmaker made plans to build a biologics plant in China capable of producing 120,000 liters in order to cash in on that market. Celltrion is conducting a phase 3 study of its Remicade biosimilar in China, and it also has biosimilars of Roche's Rituxan and Herceptin, approved elsewhere, that it could look to bring to that country's market.
Meanwhile, Celltrion shelled out $278 to Japanese drugmaker Takeda in June for 18 over-the-counter and prescription drugs marketed in the Asia-Pacific region, including diabetes med Nesina and hypertension drug Edarbi. The portfolio brought in about $140 million in sales during the fiscal year ended in March 2019, Takeda said. That deal is expected to wrap by the end of the year, with Takeda teed up to continue manufacturing and supplying the drugs to Celltrion after the transaction closes.