Amgen Settles With One Biosimilar Developer, Sues Another
May 6th 2019Last week, biosimilar developer Coherus BioSciences announced that it has reached a settlement with innovator drug maker Amgen over a trade secret case that was pending in the Superior Court of California. Separately, Amgen filed a new complaint against biosimilar developer Samsung Bioepis.
A Look Behind the US Debate Over Insulin Prices
May 6th 2019One main reason for increasing insulin prices is rebates. During the April 10, 2019 United States House Energy and Commerce Committee hearing titled “Priced Out of a Lifesaving Drug: getting Answers on the Rising Cost of Insulin” manufacturers, pharmacy benefit managers (PBMs), and congressional representatives discussed the effects rebates were having on prices. Currently, manufacturers pay rebates to health plans or PBMs in exchange for formulary access, which is a major reason we see manufacturer net pricing declining but list prices increasing.
UK Researchers Hope Adalimumab Will Prove to be Cost Effective in Dupuytren Disease
May 4th 2019Dupuytren disease (DD), a common, fibroproliferative condition of the hand that can cause contracture of the fingers, currently has no approved treatment for its early stages, and surgical intervention is often required as the disease progresses.
CBO Single-Payer Report: Highlights of Drug Pricing, Cost Containment Ideas, Implications
May 3rd 2019The Congressional Budget Office this week released a report that examines the different components of what putting together a single-payer system could involve, as well as the implications. Here we highlight 2 sections of the report that are likely of interest to those following biosimilars, drug pricing and healthcare cost containment.
Biosimilar Infliximab, Zessly, Maintains Safety and Efficacy Under Extended In-Use Conditions
May 3rd 2019The authors concluded that the physiochemical and biological analyses demonstrated that the biosimilar is not affected by reconstitution, dilution, and extended storage in infusion bags. These findings, they write, provide added reassurance to healthcare providers that the biosimilar is safe and effective under extended in-use conditions.
ACR and AF Release Guidelines for 2 Subtypes of Juvenile Idiopathic Arthritis
May 2nd 2019The American College of Rheumatology (ACR) and the Arthritis Foundation (AF) released guidelines for treating 2 subtypes of juvenile idiopathic arthritis (JIA), which affects nearly 300,000 children in the United States. One guideline discusses therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis; the other focuses on the screening, monitoring, and treatment of JIA with associated uveitis. The second guideline focuses on uveitis, which can be a chronic or acute disease.
Eculizumab May Allow Patients With MG to Reduce Immunosuppressive Therapy
May 2nd 2019The researchers wrote that that a numerically larger proportion of patients with myasthenia gravis (MG) stopped or reduced their doses of immunosuppressive therapies than started or increased, and that symptom improvement or worsening were the main reasons for changes to concomitant therapy.
Chinese Study Finds Patients Taking Reference Insulin Glargine Had Better Glycemic Control
May 2nd 2019While a study in healthy volunteers demonstrated bioequivalence of the 2 insulin products, to date, few direct comparisons of the biosimilar and the innovator have been available. A new study compared the efficacy and safety of treatment with each of the products in a retrospective analysis of hospitalized patients with type 2 diabetes and found that the reference insulin provided better fasting glycemic control than the biosimilar.
Study Finds That Disability in RA Begins 1 to 2 Years Before Diagnosis
May 1st 2019Functional disabilities start to appear in patients with rheumatoid arthritis (RA) 1 to 2 years before diagnosis, signaling that earlier diagnosis and more aggressive treatment may lessen the burden of disease, according to a study released today.
In the Leadup to EU Elections, Biosimilar and Generics Group Calls for Sustainable Market Policies
May 1st 2019European elections will take place later this month, allowing EU citizens to select their representatives in the European Parliament. The elections, being held for the first time in 5 years, are particularly significant to the healthcare sector as European stakeholders seek to reduce disparities in access to care, guard against drug shortages, and ensure a sustainable market for pharmaceuticals.
Balancing Drug Costs, Access, and Innovation: 2 Obama Administration Officials Weigh In
April 29th 2019“The path forward requires a sustainable, fair payment system in which drug prices reflect the value provided and reward innovations that improve outcomes,” wrote Robert M. Califf, MD, and Andy Slavitt.
Switching Between Biosimilar Infliximab Products Not Associated With AEs or Change in PASI
April 26th 2019This week, dermatology experts are gathering in Paris, France, for the 6th Congress of Skin Inflammation and Psoriasis International Network to discuss advances in the treatment of inflammatory skin diseases. During the congress, researchers from the University of Verona in Verona, Italy, will report findings from a study in which patients were switched between 2 different biosimilar infliximab products during treatment of chronic plaque psoriasis.
FDA Approves Samsung Bioepis' Etanercept Biosimilar, Eticovo
April 26th 2019The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). A representative from Samsung Bioepis has confirmed approval of the product to The Center for Biosimilars® in an email. The biosimilar is already approved in a variety of other markets under the name Benepali.
Bio-Thera's Bevacizumab Shows High Similarity to Reference Avastin in PK, Safety, Immunogenicity
April 25th 2019Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, has reported the results of a clinical study of its proposed bevacizumab biosimilar, BAT1706, referencing Avastin.
Eye on Pharma: Samsung Bioepis' Biosimilars Brought in $175 Million Last Quarter
April 25th 2019During the first quarter of 2019, Samsung Bioepis’ biosimilars revenue increased to $175 million, up from $128 million in the first quarter of 2018. Those numbers, say Biogen, are driven by the launch of biosimilar adalimumab, Imraldi.
PBMs Under Pressure From New Legislation and Fresh Lawsuits
April 24th 2019Earlier this month, pharmacy benefit managers (PBMs) were called before the Senate Finance Committee to answer questions about how their businesses impact drug prices for Americans. While the executives deflected criticism and pointed to issues like legal challenges to biosimilars as playing a key role in keeping drug prices high, lawmakers and officials are taking steps to rein in PBMs.
Adalimumab and Originator and Biosimilar Infliximab Have Widest Coverage for UC, CD
April 24th 2019Access to therapy for ulcerative colitis (UC) and Crohn disease (CD) may not be consistent with treatment guidelines because of payer policies that do not concur with the American Gastroenterological Association clinical pathways for the treatment of inflammatory bowel disease.
Phase 3 Trial Begins of Xbrane Biopharma's Ranibizumab Biosimilar
April 23rd 2019Xbrane Biopharma, a Swedish biotechnology company, says it is starting its phase 3 trial of its ranibizumab biosimilar, referencing Lucentis, and also set sales targets for the treatment for patients with wet age-related macular degeneration.