Celltrion Completes Phase 3 Trial for Subcutaneous Inflectra
September 4th 2018Celltrion announced last week that it has completed its phase 3 clinical trial for subcutaneous biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in other territories as Remsima), and that it will now prepare a marketing authorization application for submission to the European Medicines Agency.
Rituximab May Hold Promise in Treating IgG4-RD
September 3rd 2018IgG4-related disease (IgG4-RD), a systemic disease that can affect any part of the body and can involve fibrosis, irreversible organ damage, and secondary amyloidosis, is a rare immune-mediated condition often treated with corticosteroids or immunosuppressive drugs. The pathogenesis of the disease is not clear, but treatment with B-cell depletion therapy, in the form of rituximab, has shown positive results in some patients.
Infliximab is Effective and Well Tolerated in Pediatric Patients With CD, Study Finds
September 3rd 2018Pediatric Crohn disease (CD), which can have serious impacts on children’s growth, is increasing in incidence. Current treatments for pediatric patients with CD—such as corticosteroids or immunomodulators—may be particularly difficult for children to tolerate. Infliximab, however, has been shown to be effective and well tolerated in children, as a newly published phase 3 study in Japanese pediatric patients with CD found that infliximab improved clinical outcome measures from week 2 to week 56.
Review Suggests That Rheumatologists, Patients Need More Data on Switching to Etanercept Biosimilars
September 2nd 2018Regulators licensed the 3 etanercept biosimilars discussed for all of the indications of the reference drug on the basis of the extrapolation of indications, a practice that the authors say rheumatologists may find “anomalous and a source of debate.”
Biosimilar Drug Makers Push Back on Proposed Exclusivity Revision
September 1st 2018The Trump administration this week announced a preliminary trade deal between the United States and Mexico. Under the agreement, which looks to update the North American Free Trade Agreement, brand name drug makers will receive 10 years of exclusivity for biologics in addition to more products qualifying for this protection.
Blocking PDGF Could Make Bevacizumab More Effective in Treating Glioblastoma
August 30th 2018New research suggests that inhibiting platelet-derived growth factor (PDGF), which regulates cell growth and division, could help overcome resistance to anti–vascular endothelial growth factor treatment in glioblastoma multiforme.
Are Phase 3 Studies for Biosimilars Unethical? Avalere's Gillian Woollett Weighs In
August 30th 2018“This comes down to the assiduous care you must do for any clinical studies using human subjects…you don’t experiment on human beings unless you’re really going to learn something,” said Gillian R. Woollett, MA, DPhil, senior vice president of Avalere Health.
Pfizer Calls for FDA Guidance on False or Misleading Information About Biosimilars
August 29th 2018“Misleading statements...and the net impression conveyed by such materials, create undue confusion as to biosimilarity and interchangeability, inflate the risks associated with a physician-directed switch to a biosimilar, and cast doubt on the safety and efficacy of biosimilars generally,” read Pfizer's citizen petition.
WHO: Generic and Biosimilar Uptake Must Be Fostered Through Policy and Education
August 28th 2018The World Health Organization (WHO) has published a new report on reimbursement policies in Europe that provides a comparative review and analysis of the policies employed by 45 different European countries, and says that promoting the uptake of lower-priced medicines such as generics and biosimilars will “facilitate efficiency gains without disadvantaging patients.”
Judge Denies Hospira's Motions in Epoetin Alfa Biosimilar Case
August 28th 2018Hospira had asked the court for a judgment that producing batches of a biosimilar product is an activity protected by safe harbor provisions, that Hospira did not infringe on the ’298 patent (which Hospira claims is invalid), and that damages owed to Amgen not exceed $1.5 million per batch of the drug (if those batches were later sold). Alternatively, it sought a new trial in the case.
Sandoz's Carlos Sattler, MD, Shares His Perspective on Biosimilar Development
August 27th 2018Sandoz, with its filgrastim biosimilar (Zarxio) having been the first biosimilar to gain FDA approval and to launch in the US market, has had extensive experience in the biosimilars space. Carlos Sattler, MD, head of clinical development and medical affairs at Sandoz, recently spoke with The Center for Biosimilars® about both the biosimilar development process and the regulatory landscape that lies ahead.
Lower Pain Scores With Biosimilar Pegfilgrastim After Pediatric Stem Cell Transplant
August 27th 2018There was a significant difference observed in pain scores between pediatric patients receiving pegfilgrastim versus those receiving filgrastim after allogenic hematopoietic stem cell transplantation.
No-Deal Guidance Outlines Brexit's Impacts on the Supply and Regulation of Medicines
August 26th 2018The government is asking pharmaceutical companies to stockpile an additional 6-week supply of medicine, on top of their usual stock levels, in case normal supply routes through the European Union are disrupted.
Australia's PBAC Recommends 2 Adalimumab Biosimilars for Pharmacy-Level Substitution
August 24th 2018Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that 2 adalimumab biosimilars be treated as equivalent to the reference adalimumab, Humira, and be subject to substitution at the pharmacy level.
Researchers to Present Findings on US and European Biosimilar Use and Cost Savings
August 23rd 2018During the 34th International Conference on Pharamcoepidemiology and Therapeutic Risk Management, taking place from August 22 to 26 in Prague, Czech Republic, researchers will present findings that contrast the cost savings made possible by biosimilars in the US and European contexts.
JR-051 Shows High Degree of Similarity to Rare Disease Drug Fabrazyme
August 23rd 2018Agalsidase beta (Fabrazyme), the first Fabry disease-specific therapy to be approved by the FDA, effectively reduces globotriaosylceramide deposits. However, the drug comes with a high price tag of approximately $300,000 per patient per year, and has been subject to shortages due to manufacturing issues.
China Accepts Its First Application for an Adalimumab Biosimilar Candidate
August 22nd 2018Bio-Thera Solutions, a Chinese-based biotechnology company, says that the China National Drug Administration has accepted its Biologics License Application for a potential adalimumab biosimilar, BAT1406. This is the first proposed adalimumab biosimilar to be accepted for review in China.
With Eculizumab Biosimilars Closing in, Alexion Granted Priority Review for ALXN1210
August 22nd 2018Alexion’s existing C5 complement inhibitor, targeted by biosimilar developers, is used to treat patients with paroxysmal nocturnal hemoglobinuria, but the biologic must be administered every 2 weeks versus ALXN1210’s proposed 8-week intravenous dosing schedule.
Survey Finds Patient, Nurse Preference for Biosimilar Etanercept's Autoinjector
August 22nd 2018Because patients with rheumatoid arthritis may have compromised manual dexterity, they may have challenges with self-administering their biologic therapies. In the case of etanercept, which is typically administered once per week, device design that prioritizes ease of use can help improve patient adherence to treatment regimens.
Biosimilar Trastuzumab CT-P6 Launches in Japan, But Not For Breast Cancer
August 21st 2018The product did not earn approval for all indications of the reference Herceptin; it has been approved only for the treatment of HER2-positive gastric cancers, and not for the treatment of HER2-positive breast cancer.
A Switch to Biosimilar Etanercept Yields Mixed Results In Two UK Hospital Systems
August 21st 2018The advent of biosimilar etanercept, Benepali, in the United Kingdom has provided a significant opportunity for cost savings, given the biosimilar’s lower price than the reference Enbrel. As such, hospitals have been undertaking nonmedical switches to the biosimilar in order to benefit from these savings. During the British Society for Rheumatology 2018 Annual Conference, held in May in Liverpool, United Kingdom, investigators reported on the results of these switches, both on the financial wellbeing of the health system and on patients.
Phase 3 Trials May Be Unnecessary for Biosimilars, Paper Argues
August 21st 2018“It is now time to reassess whether the current clinical development paradigm really makes sense from a scientific and economic perspective while millions of patients still have limited or, more often, no access to life-changing/life-saving [monoclonal antibodies],” writes Francois-Xavier Frapaise, MD, PhD.
European Study: All Biologics Improve Quality of Life in RA, But Rituximab Is Cost-Effective
August 20th 2018The researchers concluded that rituximab should be considered as a preferred biologic treatment for rheumatoid arthritis (RA) therapy, though treatment of RA with any biologic medication improved quality of life significantly.