Several major health plans have recently enacted policies regarding coverage status for Remicade (infliximab) and its biosimilars, Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda). Most of these plans are limiting coverage for the biosimilar products to very specific circumstances. Some have also begun denying claims for biosimilars and instructing patients to switch to Remicade. The plans implementing… [Read More]
Search results for: Remicade
U.S. Appeals Court Invalidates J&J Patent on Remicade
(Reuters)—A U.S. appeals court on Tuesday upheld a ruling that invalidated a crucial Johnson & Johnson patent on its blockbuster rheumatoid arthritis drug, Remicade (infliximab), limiting J&J’s ability to seek damages from Pfizer Inc. over its launch of a lower-cost version of the drug. The U.S. Circuit Court of Appeals for the Federal Circuit affirmed… [Read More]
Pfizer’s Second Biosimilar of J&J’s Remicade Wins U.S. FDA Approval
(Reuters)—The U.S. Food and Drug Administration approved Pfizer Inc’s second biosimilar to Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, the company said on Wednesday. Pfizer’s Ixifi was approved for all eligible indications of Remicade, including the treatment of bowel disease Crohn’s disease and skin disorder plaque psoriasis, the drugmaker said. Biosimilars are medicines deemed… [Read More]
Pfizer Files Suit Against J and J over Remicade Contracts
(Reuters)—Drugmaker Pfizer Inc on Wednesday filed a lawsuit against Johnson and Johnson, saying its rival’s contracts with health insurers for blockbuster rheumatoid arthritis drug, Remicade, were anticompetitive and blocked sales of Pfizer’s new biosimilar. Pfizer said in the suit that Johnson and Johnson is offering discounts on its Remicade treatment in exchange for essentially excluding… [Read More]
Celltrion Accelerates U.S. Launch of Infliximab-dyyb, a Remicade Biosimilar
After winning the initial patent infringement lawsuit filed by Janssen, Celltrion Inc. is now shipping Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), to the U.S…... [Read More]
Samsung Bioepis Receives Final European Approval for Its Remicade Copy
SEOUL (Reuters)—South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe. Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said last week the biosimilar… [Read More]
Remicade Antibodies Cross-React to Biosimilars
NEW YORK (Reuters Health)—Patients with antibodies to infliximab in Remicade should not be switched to biosimilars, researchers warn. “(The) antibodies will cross-react with the new biosimilar drug, potentially reducing clinical response,” Dr. Daniel Nagore, director of research and development at Progenika Biopharma in Derio, Spain, told Reuters Health by email. “The study highlights the importance… [Read More]
FDA Approves Biosimilar to J&J’s Remicade for Multiple Diseases
(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Inflectra, a cheaper version of Johnson & Johnson’s drug Remicade (infliximab), to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. Inflectra, also known as infliximab-dyyb, is expected by some analysts to sell for a 25% discount to Remicade, which generated annual… [Read More]
FDA Advisory Panel Strongly Backs Biosimilar Form of Remicade
(Reuters)—A medical advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of a cheaper biosimilar form of Johnson & Johnson’s arthritis drug Remicade (infliximab) that could eventually batter sales of the branded product. The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc.,… [Read More]
Antibodies to Remicade Cross-React with Biosimilar Remsima
NEW YORK (Reuters Health)—Antibodies to infliximab in patients with inflammatory bowel disease (IBD) treated with Janssen’s Remicade cross-react with the biosimilar Remsima from Celltrion (distributed as Inflectra by Hospira in the U.S.), researchers from Israel report. “The cross-reactivity of anti-Remicade antibodies with Remsima attests to shared immune triggering points (epitopes) on these two agents, and… [Read More]
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