Jackie Syrop

Hospitals classified as 340B institutions are playing an increasingly large role in oncology care, and the rapid growth in the federal 340B program has resulted in big changes in the oncology drug marketplace, according to a recent white paper released by the Community Oncology Alliance.

A significant proportion of patients with Crohn disease (CD) who initially respond to infliximab therapy experience secondary loss of response with symptom flares. Treatment intensification (using increases in dose, dose frequency, or a combination of both to implement intensification) is a suggested strategy for regaining response.

The pharmaceutical industry trade and lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) sued California state officials in federal court on December 8, 2017, over California’s new drug pricing law, which the group states is “unprecedented and unconstitutional.”

Evaluate Group’s EP Vantage pharma and biotech preview of 2018 predicts that the uptick in the pharmaceutical and biotech sectors that occurred in 2017 is likely to continue into 2018.

Results from a phase 1 clinical trial show that Sandoz’s proposed pegfilgrastim biosimilar (LA-EP2006) matched the reference biologic, Amgen’s Neulasta, in terms of safety, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy subjects.

No differences in drug levels or disease activity were found when adult patients with inflammatory bowel disease (IBD) were switched from originator infliximab (Remicade) to a biosimilar infliximab (Inflectra) as part of routine care, according to the results of a Dutch study.

A new report from calls for big changes in how US pharmaceuticals are priced, promoted, and sold so that treatments are more affordable and equally available to all Americans, as market mechanisms that would usually moderate prices have been blunted or eliminated.

The failure rate of biosimilars in clinical trials is considered high because of the complex manufacturing process and the high variability expected for biologics. With associated development costs for a biosimilar estimated to be $100 million, there is a high risk-cost relationship in the establishing clinical biosimilarity.

CVS Health has agreed to purchase Aetna, a transaction that would combine CVS’s retail pharmacies with Aetna’s health insurance company in a $69 billion deal that could create a company with annual revenue of $240 billion, and that has the potential to reshape the US healthcare system.

Janssen-Cilag International’s biologic drug guselkumab (Tremfya) has received approval from the European Commission (EC) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

A new review discusses the systemic treatment of psoriasis and recommends biologics and biosimilars for long-term treatment of psoriasis because of their better tolerability and safety compared with other systemic treatments, which are limited largely by poor tolerability and cumulative toxicity.

The United Kingdom's National Institute for Health Research (NIHR), part of the National Health Service (NHS), has created a website to educate the public about biosimilar drugs.

A retrospective Chinese study of 59 people with brain edema related to metastatic cancer finds that bevacizumab (Avastin) is an effective and relatively safe treatment for brain edema, with a low risk for cerebral hemorrhage.

A recently unsealed lawsuit alleges that drug maker Eli Lilly illegally worked with Healthstar Communications and VMS Biomarketing to provide free nursing services to induce healthcare providers to prescribe the drug maker’s insulin products Humalog and Humulin.

A recent Health Technology Assessment (HTA) report by the United Kingdom’s National Institute for Health and Care Excellence (NICE) concludes that adalimumab, etanercept, and ustekinumab improve the symptoms of psoriasis in children and young people in the short term, but the cost-effectiveness of these medications requires further study.

In an effort to better address the needs of patients taking reference etanercept (Enbrel), Amgen has launched an ergonomically designed cartridge with a reusable auto-injector in the United States as an additional administration option.

Australian researchers Kellie A. Mouchemore, PhD, and colleagues urge caution in the use of granulocyte colony stimulating factor (G-CSF) in neutrophil recovery following chemotherapy for breast cancer because there is increasing evidence that G-CSF can promote metastasis.

Theradiag, a French company that specializes in in vitro diagnostics and theranostics, has entered into a partnership agreement with Biogen to provide its Lisa Tracker kits to monitor patients treated with Biogen’s infliximab biosimilar Flixabi, which was approved in Europe in 2016.

The ability to identify factors that predict efficacy of anti–tumor necrosis factor (TNF) agents is crucial if clinicians are to optimize treatment and minimize side effects and costs.

Interest in needle-free drug delivery has increased as biologics manufacturers look for ways to give their originator drugs a competitive advantage over oncoming biosimilar competition.

Several posters at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, compared the efficacy of originator and biosimilar infliximab in the treatment of rheumatic diseases.

Three presentations at the 2017 American College of Rheumatology’s Annual Meeting in San Diego, California, covered research on the real-world treatment of rheumatology patients with originator infliximab therapy and biosimilar infliximab (CT-P13; Inflectra and Remsima) and etanercept (Benepali) therapy.

Four presentations on Monday at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, California, covered research comparing reference etanercept to 4 proposed biosimilars: SB4, LBEC0101, CHS-0214, and GP2015.

Today, 4 presentations at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, California, covered research on switching studies concerning etanercept and infliximab biosimilars.

Three presentations at this week’s 2017 American College of Rheumatology Annual Meeting in San Diego, CA, cover research on pharmacokinetic equivalence, safety, and switching of 2 proposed adalimumab biosimilars, GP2017 and CHS-1420.

CMS has announced a change to its present policy on biosimilar reimbursement, stating that it will begin issuing unique Healthcare Common Procedure Coding System (HCPCS) codes to each individual biosimilar product.

The FDA has accepted Genentech’s supplemental Biologics License Application (sBLA) for its innovator bevacizumab (Avastin) in combination with carboplatin and paclitaxel chemotherapy, followed by Avastin alone, for the front-line treatment of women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Momenta Pharmaceuticals and Mylan N.V. announced today that M834, the companies’ proposed biosimilar of Bristol-Myers Squibb’s Orencia (abatacept), did not meet its primary pharmacokinetic (PK) endpoints in a phase 1 study comparing the PK, safety, and immunogenicity of M834 compared with US- and EU-sourced Orencia.

Revisions to the CMS billing code system could be announced November 1, 2017, potentially impacting how biosimilars will compete with reference products.

More than 90% of Americans believe that the cost burden of cancer is too high, according to a large, nationally representative survey conducted for the American Society of Clinical Oncology (ASCO).