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Pediatric Experts Caution Against Switching Kids with IBD to Biosimilars

European pediatricians say caution and long-term safety and efficacy studies are needed before switching children with IBD to biosimilars.   A group of 10 pediatric specialists has published a statement calling for children with inflammatory bowel disease (IBD), who are already doing well on specific biologic medications, not to be switched to recently-approved biosimilar products.   … Continue reading Pediatric Experts Caution Against Switching Kids with IBD to Biosimilars

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Study Finds Neupogen Biosimilar Safe for Breast Cancer Patients

A filgrastim biosimilar has shown comparable safety and efficacy to its reference drug in phase 3 clinical trials on breast cancer patients.   A new study published in the journal Annals of Oncology has shown the biosimilar filgrastim, EP2006 is similar to the reference product, Neupogen, with no clinically meaningful differences in efficacy or safety … Continue reading Study Finds Neupogen Biosimilar Safe for Breast Cancer Patients

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Humira Biosimilars to be Most Successful

A Bloomberg survey found industry players predict Humira biosimilar copies will be most successful when launched in the EU and U.S.   According to a Bloomberg Intelligence survey, biosimilar copies of AbbVie’s top-earning autoimmune anti-inflammatory drug, Humira, are expected to be the most successful biosimilars to be launched in the U.S. and Europe in the … Continue reading Humira Biosimilars to be Most Successful

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Finnish Study Finds Patients Safely Switch from Remicade to Biosimilar

A recent Finnish study has demonstrated that patients with rheumatic diseases can be safely and effectively switched from original-brand medicine to a biosimilar version.   A Reuters article reports that the results of the independent study were presented at the recent European League Against Rheumatism Congress in Rome, by one of its researchers, Tuulikki Sokka … Continue reading Finnish Study Finds Patients Safely Switch from Remicade to Biosimilar

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Merck, Biogen, Samsung Partnerships Present Promising Data at EULAR Congress

At the recent EULAR Congress, the joint ventures between Merck, Biogen and Samsung bore fruit with promising biosimilars data presented.   As emerging and established biopharmaceuticals companies scramble for a place in the biosimilars space, clinical trial data presented at the recent European League Against Rheumatism (EULAR) Annual Congress in Rome shows promise for more … Continue reading Merck, Biogen, Samsung Partnerships Present Promising Data at EULAR Congress

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Study Finds Remicade Antibodies Cross-React with Remsima

An Israeli study found similar immune responses to the brand name and biosimilar infliximab among patients with inflammatory bowel disease.   “The study [of 86 patients] found that patients with inflammatory bowel disease (IBD) who produce antibodies to infliximab when treated with Janssen’s Remicade also cross-react with Celltrion’s biosimilar, Remsima. One author of the study, Dr. … Continue reading Study Finds Remicade Antibodies Cross-React with Remsima

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ANVISA Approves First Infliximab Biosimilar in Brazil

The National Health Surveillance Agency (ANVISA) in Brazil has approved the use of the monoclonal antibody Remsima (infliximab) from Hospira Inc. and its partner Celltrion.   Remsima is responsible for the treatment of, “rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn’s disease in adults and children, fistulizing Crohn’s disease (advanced), colitis and ulcerative rectocolitis.” This … Continue reading ANVISA Approves First Infliximab Biosimilar in Brazil

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