Package Leaflets for EU Biosimilars May Negatively Impact Adherence, Study Says
January 21st 2019The package leaflet provided to a patient with any drug product includes crucial information about a given therapy that can increase adherence and appropriate use of the product. To help make these leaflets as useful as possible for patients, in 2009, the European Commission published a new guideline on the readability of these labels with the aim of making them easier for patients to understand.
EU Draws Closer to Adopting SPC Manufacturing Waivers for Biosimilars and Generics
January 20th 2019The European Union has announced that The Committee of the Permanent Representatives of the Governments of the Member States to the European Union (Coreper) agreed this week on the European Council’s draft regulation that grants an exception to Supplementary Protection Certificates (SPCs).
Proposed Biosimilar Shows Similar Glycosylation, Primary Structure, In-Vitro Functionality to Enbrel
January 19th 2019In a recent comparability analysis, a proposed biosimilar to etanercept (that the developers hope to sell as Altebrel) underwent direct comparison to the reference and was found to have a high similarity in terms of glycosylation, primary structure, and in-vitro functionality.
ICER to Review Price Hikes to Prescription Drugs
January 18th 2019The Institute for Clinical and Economic Review (ICER), an independent, nonprofit organization that seeks to improve healthcare value by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures, has announced that it is undertaking a new annual analysis—an Unsupported Price Increase report—that will review significant prescription drug prices increases and determine whether those increases are supported by new clinical evidence.
New Paper Seeks to Clarify the US Position on Interchangeability
January 18th 2019A new paper, published this week in Current Medical Research and Opinion, seeks to clarify the US definition of interchangeability and differentiate it from the separate concepts of automatic substitution and physician-mediated switching.
Study Finds that CT-P13 May Be Effective in Takayasu Arteritis
January 17th 2019Researchers recently sought to evaluate the efficacy and safety of infliximab biosimilar CT-P13 in the treatment of Takayasu arteritis (TAK), a granulomatous inflammatory vasculitis that affects the aorta and can cause aneurysms to form. Some patients with TAK benefit from corticosteroids or second-line, small-molecule immunosuppressive agents, but there is a demand for more effective therapeutic options.
Rituximab Biosimilar Is Safe, Effective, and Cost-Saving in RA, but When Will US Patients Benefit?
January 17th 2019When Celltrion and Teva’s biosimilar rituximab, CT-P10, earned FDA approval under the brand name Truxima in late 2018, it was authorized only for oncology indications, as the drug’s sponsors did not seek indications in inflammatory diseases because of issues related to patent exclusivity on some indications. However, the biosimilar has shown efficacy in treating rheumatoid arthritis (RA), and a European analysis found that the budget impact of introducing CT-P10 could dramatically reduce the cost to treat severe RA.
As No-Deal Brexit Becomes More Likely, Drug Makers Warn of "Immediate Threat" to Patients
January 17th 2019After the UK Parliament voted to reject Prime Minister Theresa May’s proposed Brexit deal with just weeks to go before the United Kingdom’s planned withdrawal from the European Union, the pharmaceutical industry has warned that a no-deal Brexit poses “tangible and immediate threats” to patient safety and public health.
New Research Investigates Shelf Life, Device Usability of Biosimilar Adalimumab
January 16th 2019Samsung Bioepis’ biosimilar adalimumab, SB5, has been approved in the European Union under the name Imraldi on the basis of clinical studies including a phase 3 study in patients with rheumatoid arthritis. Now that the biosimilar has begun to make its way to EU patients, investigators are publishing new data on other key facets of the product, including its shelf life and device usability.
Shifting Medicare Part B to Part D Could Increase Out-of-Pocket Spending for Patients, Study Finds
January 14th 2019In May 2018, as part of the Trump administration’s blueprint to reduce drug costs for American patients, HHS proposed shifting coverage of some Medicare Part B drugs to Medicare Part D. However, a new study, published today in JAMA Internal Medicine, finds that shifting reimbursement of these drugs could increase out-of-pocket spending for some Medicare beneficiaries.
New Research Finds Switching to CT-P13 Is Safe in IBD, and So Is Switching to the Reference
January 14th 2019The body of evidence demonstrating the safety and efficacy of biosimilar infliximab, CT-P13 (Inflectra, Remsima), is growing, particularly in the extrapolated indication of inflammatory bowel disease (IBD). This month saw the publication of 2 new studies that provided reassuring data on CT-P13, one of which focused on switching pediatric patients with IBD to CT-P13, and the second of which explored switching to the reference infliximab from the biosimilar in adults with IBD.
Infographic: 7 Biosimilar Takeaways from the J.P. Morgan Healthcare Conference
January 13th 2019During this year’s investment symposium, held in San Francisco, California, from January 7-10, biosimilars featured prominently in drug makers’ and regulators’ visions for 2019 and beyond. Here are 7 key takeaways from the conference’s biosimilars presentations.
Alexion's Second C5 Complement Inhibitor Requires Less Frequent Dosing, Carries New Patents
January 12th 2019Eculizumab must be administered every 2 weeks, versus every 8 weeks for the newly approved ravulizumab. Another possible advantage for Alexion is that the newer drug also has the benefit of new patent exclusivities that could help Alexion stave off the impact of competition from oncoming eculizumab biosimilars.
Celltrion Says Its Biosimilar Has Gained 56% of the European Infliximab Market
January 11th 2019Biosimilar developer Celltrion has seen strong success with its biosimilar infliximab, CT-P13, which is marketed in the United States as Inflectra and in other territories as Remsima. This week, the company said that its product has captured 56% of the infliximab market in Europe as of the third quarter of 2018.
Hospital Group Making Generic Drugs Adds 12 Additional Members
January 11th 2019Civica Rx, the nonprofit generic drug company formed last year by 5 health systems in order to combat drug shortages and high prices for generic drugs, added 12 additional health systems this week, bringing the total to 750 hospitals in the United States joining the venture so far.
MAPLE Study Supports Clinical Equivalence of ABP 215 and Reference Bevacizumab
January 11th 2019This week, investigators published the results of the MAPLE study, a phase 3 trial of Amgen’s bevacizumab in comparison with the reference, Avastin, in patients with advance nonsquamous non–small cell lung cancer who were also receiving first-line chemotherapy with carboplatin and paclitaxel.
Azar Says "All Options Are on the Table" to Bring Down Drug Prices
January 10th 2019Following promises of halts to increases in drug prices in 2018, pharmaceutical makers began January by raising the prices of more than 250 drugs. Now, HHS Secretary Alex Azar is calling on companies to bring their list prices back down.
UK Patients Report Negative Experiences With Switches to Biosimilars
January 9th 2019While 63% of respondents who had switched to a biosimilar said that they had been consulted in some form prior to the transition, 37% said that they had not been consulted (despite the fact that National Health Service guidelines require the patient to be consulted about such a switch).