Switching From Reference Adalimumab to Biosimilar ABP 501 Does Not Cause Immunogenicity
July 13th 2018Transitioning from reference adalimumab (Humira) to Amgen’s FDA- and EU-approved adalimumab biosimilar ABP 501 (Amgevita) was not associated with increased immunogenicity over an observation period of 72 weeks in patients with rheumatoid arthritis, according to the results of a study presented at the European Congress of Rheumatology.
Senators Urge FTC to Investigate AbbVie Humira Settlements
July 13th 2018Earlier this month, US Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the FTC to “examine whether makers of biologic medicines are using strategies like ‘pay-for-delay’ to hinder or delay biosimilars from entering the market.”
Amgen's Infliximab Biosimilar Demonstrates Top-Line Results in Phase 3 Trial
July 12th 2018Amgen recently announced top-line results from a phase 3 clinical trial that sought to evaluate the safety and efficacy of its proposed infliximab biosimilar, ABP 710, compared with the reference product (Remicade) in patients with moderate-to-severe rheumatoid arthritis (RA).
Low-Dose Strategy for Etanercept in Psoriatic Arthritis Can Maintain Remission
July 11th 2018Italian researchers report that 72% of their trial participants being treated for psoriatic arthritis achieved sustained remission with ETN 25 mg biweekly, which was maintained a year after treatment initiation.
FDA Announces Draft Guidance for Labeling of Drug and Biological Products
July 11th 2018The FDA recently released a draft guidance document that provided an overview of the content and format of information sponsors should include in the “Indications and Usage” section of a drug label for drugs and biologics.
Study Finds Significant Unmet Needs Remain With RA Treatment
July 10th 2018Despite progress in the successful treatment of patients with rheumatoid arthritis (RA) who are using conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) and biological DMARDs (bDMARDs), a Greek study has found that a considerable number of patients are still not achieving low disease activity (LDA) despite having been treated following established recommendations for RA therapy.
Mylan Receives FDA Form 483 Noting 13 Inspection Observations
July 10th 2018Last week, the FDA issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Virginia. The FDA cited 13 inspection observations, including failure to follow proper quality control protocols, lack of adequate cleaning of utensils and equipment, and ineffective laboratory controls and sampling, among others.
FDA Draft Guidance Explains Assessment of User Fees Under BsUFA
July 9th 2018The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The guidance is meant to address various industry inquiries around the implementation of the Biosimilar User Fee Amendments II (BsUFA II).
Observational Study Finds High Patient Satisfaction With Prefilled Biosimilar SB4 Pen
July 6th 2018A survey of German patients who used a prefilled pen for subcutaneous delivery of biosimilar etanercept SB4 has reported a very high level of patient satisfaction with the product following an interim analysis.
Norwegian Study Finds Nonmedical Switch to Biosimilar Etanercept SB4 Well Tolerated in RA
July 3rd 2018A preliminary study among patients with rheumatoid arthritis (RA) in Norway who were switched from originator etanercept to its biosimilar (SB4) for nonmedical reasons found that patients had good tolerance for the switch to the biosimilar, with no impairment in disease measures.
Intratumoral Injections of Bevacizumab Could Help Prevent AEs Associated With Systemic Therapy
July 3rd 2018Intravenous administration of the anti–vascular endothelial growth factor treatment bevacizumab at high doses can result in serious, systemic adverse events (AEs). Additionally, tumors can become resistant to therapy and adopt a more invasive growth pattern. Thus, delivering bevacizumab for the treatment of cancer at a lower dose in a manner that avoids systemic AEs is necessary.
Bevacizumab May Have a Role in Treating Eales Disease
July 1st 2018Eales disease (ED) is a common, idiopathic, inflammatory retinal vasculitis that particularly affects young adults. Current treatments available for ED include corticosteroids, laser photocoagulation, retinal cryotherapy, and surgery, but a recent study found that using intravitreal bevacizumab injections may produce better outcomes and reduce the need for surgery.
Study Examines Potential Role of Biologics in Treating Primary Sclerosing Cholangitis
June 30th 2018Primary sclerosing cholangitis (PSC) is a chronic, immune-mediated, progressive biliary disease that is closely associated with inflammatory bowel disease (IBD). PSC has no cure, and up to 40% of cases eventually require patients to receive liver transplants. Given the efficacy of biologics in treating IBD, the potential to treat PSC with these same drugs is a matter of interest for healthcare providers.
Canada Allows Aligned Regulatory Drug Reviews Between Health Canada and HTA Orgs
June 29th 2018Health Canada, Canada’s governmental health agency, announced that there is now an option for all biological and pharmaceutical new drug submissions to request aligned regulatory reviews between Health Canada and health technology assessment (HTA) organizations.
Biosimilar Nonmedical Switching Must Never Undermine Patient Safety
June 29th 2018While managing costs is extremely important to physicians and their patients, achieving and maintaining disease control without increasing the risk of complications or toxicities must remain the primary goal in the treatment of chronic inflammatory diseases.