News

Results of a recent survey demonstrate that Asian physicians are less confident in using biosimilars than their European peers are.

Denmark’s national authorities have confirmed to The Center for Biosimilars® that AbbVie's Humira did not offer the lowest price for adalimumab in either of 2 national tenders.

In many regulatory territories, patients with Crohn disease (CD) who lose response to adalimumab at a dose of 40 mg given every other week may be given an escalation to 40 mg every week. However, in Japan, where adalimumab is typically administered by a healthcare provider rather than by the patient, a study investigated the efficacy, safety, and pharmacokinetics (PK) of adalimumab after a dose escalation to 80 mg every other week as a means to reduce the need for additional patient appointments.

During the 83rd Annual Scientific Meeting of the American College of Gastroenterology, researchers from the United Kingdom reported on yet another large, nonmedical switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), this time in the Pennine Acute Hospitals Trust.

The researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan.

Samsung BioLogics, parent company of the biosimilar development business Samsung Bioepis, has been fined by the Republic of Korea’s financial regulatory body, The Securities and Futures Commission, after the commission ruled that Samsung had committed fraud.

Three quantification assays optimized for therapeutic drug monitoring of Remicade can be used to monitor levels of the infliximab biosimilar Flixabi (sold in the United States as Renflexis).

The Center for Biosimilars® recaps the top news for the week of November 12, 2018.

Rituximab is frequently used off-label as a treatment for relapsing-remitting multiple sclerosis (MS) because it induces the depletion of circulating B-cell and T-cell lymphocytes and targets CD20 protein in B cells that are responsible for the production of antibodies.

Results of a small Greek observational study suggest that biosimilar infliximab may be an effective alternative for the treatment of patients with inflammatory bowel disease (IBD) who have active disease and experienced a loss of response to innovator infliximab (Remicade).

Pfizer announced today that it has launched its epoetin alfa biosimilar, Retacrit, at a substantial discount to the reference product, Epogen.

The best predictors of which US counties’ patients are most likely to be prescribed higher-priced drugs are income, healthcare costs, and access to exercise opportunities, according to a new study published online in Nature Communications.

Among long-term responders, first-line bevacizumab-based therapy is more effective in patients with HER2-negative metastatic breast cancer (MBC) who were not previously treated with taxanes, a recent Spanish study suggests.

Innovent Biologics, a China-based biopharmaceutical company, announced that its new drug application for its proposed adalimumab biosimilar IBI303, referencing Humira, was accepted by the National Medical Products Administration.

During this week’s International Society for Pharmacoeconomics and Outcomes Research 2018 European meeting, the role of biosimilars in oncology is the subject of several research presentations, all of which underscore the importance of these agents in increasing patient access and driving down costs.

This week, healthcare economics stakeholders have gathered in Barcelona, Spain, for the 2018 annual European meeting of the International Society for Pharmacoeconomics and Outcomes Research. During the meeting, research teams from around the globe are presenting findings that support the use of biosimilar infliximab as a cost-saving measure.

When treating any disease, adherence is key. Specifically, however, in inflammatory bowel disease (IBD), adhering to biologic therapy is critical in the management of these diseases, as previous research has demonstrated that a medication possession ratio (MPR) of less than 0.86 significantly increases the risk of disease flare.

Early-onset inflammatory bowel disease (IBD) can have a more aggressive course than later-onset disease, making prompt treatment for children with IBD especially important. Given the high cost of biologics that treat pediatric IBD—adalimumab and infliximab—biosimilars are emerging as an important cost-saving option that can prevent the premature termination of biologic therapy for financial reasons.

As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders.

AbbVie has struck agreements with multiple developers over biosimilar adalimumab, forestalling US market entry until 2023. Here's when each product could potentially reach US patients.

Genentech says that the biosimilar company benefited from its proprietary information, and a hearing is scheduled for December 13, 2018.

During the Community Oncology Alliance Payer Summit, held October 29-30, 2018, The Center for Biosimilars® had the opportunity to sit down with several oncologists to discuss their opinions on and experiences with biosimilars.

In its investor call on Thursday, Coherus Biosciences revealed that it will launch its biosimilar pegfilgrastim, Udenyca, at a 33% discount to the reference Neulasta.

The Center for Biosimilars® recaps the top news for the week of November 5, 2018.

After the votes from the midterm elections were counted Tuesday and the Democrats had gained a majority in the US House of Representatives while Republicans reinvigorated their hold on the Senate, it was clear that a hot topic on voters’ minds was the high cost of drugs in the United States; however, questions remain as to what the newly elected officials will be able to accomplish to reduce prices.

The Canadian Agency for Drugs and Technologies in Health, the Canadian entity responsible for health technology assessments (HTAs), has released a new report that explores international policies related to biosimilars and the factors that facilitate their use.

Allergan’s dry-eye drug, Restasis, has been the subject of complex legal wrangling involving the transfer of patents that could next extend to the Supreme Court of the United States. Now, in a separate twist in the story of generic competition for the cyclosporine ophthalmic emulsion, generic developer Teva has sued the FDA in the United States district court for the District of Columbia over Teva’s status as the first filer of a generic version of the drug.

According to the earnings report, aflibercept sales in the United States increased 7% to $1.02 billion versus third quarter 2017 results.

Notably, Oncobiologics revealed that it is developing the bevacizumab product as an innovator therapy, and it will not use the biosimilar pathway for eventual approval.

Momenta Pharmaceuticals announced yesterday that it has reached a settlement with Humira-maker AbbVie over a proposed biosimilar adalimumab, M923.