European Competition for Trastuzumab to Heat Up as ABP 980 Gains Positive CHMP Opinion
March 25th 2018Amgen and its partner Allergan announced Friday that their ABP 980, a trastuzumab biosimilar referencing Herceptin, has gained a positive opinion for marketing from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Trump Promises "Major" News on Drug Pricing "In About a Month"
March 24th 2018Earlier this week, President Donald Trump made a speech in New Hampshire to discuss the administration’s efforts in combatting both the opioid crisis and high drug prices. In the speech, Trump alluded to a possible press conference in the near future that would discuss potential proposals in reducing prescription drug prices.
CHMP Grants Sandoz Positive Opinion for Proposed Infliximab Biosimilar
March 23rd 2018Novartis division Sandoz announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the marketing authorization of biosimilar infliximab.
Rituximab Induction Is Cost Effective for Asymptomatic Advanced Follicular Lymphoma
March 23rd 2018Rituximab induction therapy has the highest probability of cost effectiveness in treating newly diagnosed patients with asymptomatic advanced follicular lymphoma, according to a study published in the British Journal of Haematology.
AHIP's New CEO Supports Reducing Drug Costs Through Robust Biosimilar Market
March 22nd 2018Insurance lobbying group, America’s Health Insurance Plans (AHIP), recently named Matt Eyles as its next president and CEO beginning June 1. Eyles, currently AHIP’s chief operating officer, recently gave a statement about his priorities for the organization once he begins his tenure.
Noninvasive Evaluation Can Help Determine Infliximab's Efficacy in IBD
March 22nd 2018In patients with IBD, it was found that gut microbial levels lack in diversity. After receiving infliximab treatment, CD patients restored their microbial diversity and increased their Clostridiales levels. Clostridiales reduced proinflammatory bacteria, produced short-chain fatty acids, and induced an immune response.
Dr Angus Worthing Addresses Recent Physician Letter Sent to HHS
March 21st 2018In an interview with The Center for Biosimilars®, Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology (ACR) Government Affairs Committee, discussed the letter recently sent to HHS addressing physician concerns with proposed legislation.
Adalimumab Could Help Treat Corticosteroid- and Infliximab-Resistant IRIS
March 21st 2018Although corticosteroids are a mainstay of treatment for immune reconstitution inflammatory syndrome (IRIS), some patients with HIV are refractory to corticosteroid therapy. Infliximab may be useful in treating IRIS, but little is known about patients who are also refractory to infliximab therapy.
First CSR Data Published in FDA's Clinical Data Summary Pilot Program
March 20th 2018The FDA’s Center for Drug Evaluation and Research has launched its pilot to publicly release clinical study report (CSR) data from pivotal clinical trials as part of a greater push for agency transparency in the approval of new drugs.
Study Finds Higher Rates of Discontinuation Due to Remission Among Infliximab Users With RA
March 19th 2018A multi-center retrospective study of Japanese patients, newly published in PLOS One, sought to describe treatment persistence and reasons for discontinuation among patients who were treating their rheumatoid arthritis with 1 of 7 biologic agents: adalimumab, etanercept, infliximab, golimumab, certolizumab pegol, tocilizumab, and abatacept.
Oregon Enacts Law to Demand Transparency in Drug Pricing
March 17th 2018House Bill 4005 requires drug manufacturers to compile a report on a prescription drug if the price was $100 or more for a 1-month supply (or course of treatment lasting less than 1 month) and if the net price increased by 10% or more.
Registry Data Suggest That Rituximab is Safe and Efficacious in Refractory Lupus
March 15th 2018Data on the use of rituximab in treating patients with systemic lupus erythematosus (SLE) has been far from clear; 2 randomized controlled trials of rituximab in patients with SLE failed to meet their primary endpoints, while open-label trials have reported the drug’s efficacy in this indication.
Oral Anti-TNF Agent Met Key Efficacy Endpoints in Phase 2 Clinical Trial
March 15th 2018This week, Israel-based Protalix BioTherapeutics, Inc, announced positive results from a phase 2 clinical trial for its orally administered anti–tumor necrosis factor (anti-TNF) drug, OPRX-106, a plant cell–expressed recombinant human TNF receptor II fused to an IgG1 Fc domain.
Former Roche Employees Investigated for Theft, Black-Market Sale of Rituximab
March 14th 2018Between 2013 to 2015, doctors at St. Petersburg City Hospital 15 wrote out prescriptions for 34 packages of the 500-mg dose and 31 packages of 100-mg dose, and the suspects allegedly then sold the stolen drugs for a total of around $51,000.
No Negative Impact on Quality of Life With Subcutaneous Trastuzumab
March 14th 2018Patients without comorbidities who received subcutaneous trastuzumab with their chemotherapy and endocrine therapy showed a significant improvement in emotional function, and reported that they were less upset by hair loss than the patients in the control group.
IQVIA Report Predicts the "Next Large Wave of Biosimilars"
March 13th 2018The IQVIA Institute for Human Data Science (formerly the IMS institute) has released a new report making predictions for the healthcare landscape in 2018 and beyond, and the report’s authors see biosimilars as having a key role in developed markets in the years ahead.
Rituximab Biosimilar to Launch in Turkish Market
March 13th 2018The biosimilar was developed by Dr Reddy’s Laboratories and first approved in India in 2007. A collaboration was announced in 2016 of Dr Reddy’s and TRPharm, under which TRPharm will register and commercialize a total of 3 biosimilar products of Dr Reddy’s in Turkey.
Study: Biosimilar Infliximab Most Cost-Effective Biologic for Fistulizing CD
March 13th 2018Randomized controlled trials have established the clinical efficacy and safety of infliximab in treating fistulizing Crohn disease (CD), and while evidence for adalimumab and vedolizumab in this indication is weaker, these drugs are also used in clinical practice, sometimes in treatment sequences of biologics, to treat fistulizing CD. In Europe, where access to biologic drugs is largely driven by budgetary considerations, biosimilars have the potential to improve access to treatment.