Yesterday, the FDA’s Arthritis Advisory Committee convened for a vote on whether to recommend approval of Eli Lilly’s baricitinib, a Janus kinase (JAK) inhibitor that the company hopes to sell as Olumiant for the treatment of rheumatoid arthritis (RA). The advisory committee voted in favor of recommending approval of a dose of 2 mg and against recommending approval of a higher 4-mg dose because of concerns about safety, including the risk of thrombosis.
Yesterday, the FDA’s Arthritis Advisory Committee convened for a vote on whether to recommend approval of Eli Lilly’s baricitinib, a Janus kinase (JAK) inhibitor that the company hopes to sell as Olumiant for the treatment of rheumatoid arthritis (RA). The advisory committee voted in favor of recommending approval of a dose of 2 mg and against recommending approval of a higher 4-mg dose because of concerns about safety, including the risk of thrombosis.
While the FDA’s briefing document for the committee meeting said that the agency’s review team agreed that Eli Lilly’s data demonstrated the efficacy of the proposed drug at both doses, it had lingering concerns about safety and noted that many adverse events (AEs) associated with baricitinib appeared to be dose-dependent. Because Eli Lilly’s trial design for baricitinib, limited safety data for the 2-mg dose complicated the benefit/risk assessment of the lower dose.
"While we are disappointed with the Advisory Committee's assessment of the data for the 4-mg dose, we are confident in the positive benefit—risk profile of both the 2-mg and the 4-mg doses. We look forward to continuing our work with the FDA on our New Drug Application and are hopeful that baricitinib will receive approval in the coming months,” Christi Shaw, MBA, president of Lilly Bio-Medicines, said in a statement.
Baricitinib had been widely believed to have blockbuster potential in the RA space, given the fact that it outperformed adalimumab (Humira) in terms of patient-reported outcomes in a phase 3 study, and has an oral route of administration (while anti—tumor necrosis factor biologics and biosimilars must be infused or injected). With biosimilars for the top-selling Humira not expected to launch in the United States until 2023, baricitinib could, if approved, exert pressure on Humira.
While the advisory committee’s assessment came as a disappointment for Eli Lilly, this week’s vote is not the first such setback for baricitinib; the FDA issued a Complete Response Letter for baricitinib in April 2017 after concerns about safety. In fact, JAK inhibitors as a class have come under scrutiny for their safety profiles; a recent systematic review of the FDA’s Adverse Event Reporting System found elevated reporting for thromboembolic AEs for 2 approved JAK inhibitors, tofacitinib (Xeljanz) and ruxolitinib (Jakafi), raising the question of whether a class-wide safety issue might exist for JAK inhibitors.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.