News

Before the Wisconsin State Assembly’s health committee today is Assembly Bill 679, an act to address biosimilar substitution at the pharmacy level.

Biosimilars have reached a tipping point in the US market, according to a new drug pricing forecast from consulting company Vizient.

The FDA has issued a warning letter to Celltrion, maker of the infliximab biosimilar Inflectra. The company announced today that, on January 30, the company received a letter from the agency that “raises issues related to certain manufacturing process[es]” at its Incheon, Republic of Korea facility.

The American College of Rheumatology (ACR), which represents over 9500 rheumatologists and rheumatology health professionals, recently submitted a letter to HHS in response to the department’s request for information on Promoting Healthcare Choice and Competition Across the United States.

Higher levels of cancer-related financial toxicity are associated with decreased quality of life, poorer treatment adherence, and poorer survival for adult patients with cancer.

The early weeks of 2018 held substantial developments for oncology biosimilars in the United States and around the world, with new products on the horizon and evolving challenges in bringing these drugs to the marketplace.

A study newly published in the Journal of Clinical Oncology found that SB3, a proposed trastuzumab biosimilar being developed by Samsung Bioepis, demonstrated equivalence with European-sourced reference trastuzumab (Herceptin) in terms of breast pathologic complete response (bpCR) rate. Safety and immunogenicity for the 2 drugs were also similar.

The Therapeutic Goods Administration has announced that it will not use 4-letter suffixes in naming biologic and biosimilar medicines (as the FDA currently requires).

Trump said of Azar, who was confirmed by a vote of 55 to 43 on January 24 to replace Tom Price, MD, as Secretary of HHS, “He’s going to get those prescription drug prices way down…it’s going to come rocketing down.”

Jeff Bezos, Amazon’s founder and CEO, said that reducing healthcare’s burden on the economy while improving outcomes for employees and their families would be worth the effort, and the 3 companies had the talented experts with fresh approaches and a long-term orientation that will be key to success.

Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, is expected to post its first profits in 2018, according to estimates made by a Republic of a Korea-based securities firm.

On January 26, the Biosimilars Council (a division of the Association for Accessible Medicines) filed an amicus brief opposing Johnson & Johnson’s motion to dismiss a complaint brought by Pfizer over its biosimilar infliximab, Inflectra, which references Johnson & Johnson’s innovator product, Remicade.

During the American College of Rheumatology's (ACR) Winter Rheumatology Symposium last week in Snowmass, Colorado, one of the sessions comprised a panel addressing treatment options for inflammatory arthritis. One case study the panel addressed the pros and cons of dose reduction versus an increase in dosing interval of a biologic for a patient with rheumatoid arthritis (RA) who has achieved low disease activity or remission.

A recent study, set in the Netherlands, sought to assess patients’ attitudes about redistributing unused, subcutaneously administered biologic drugs, which could allow potential cost savings for the health system. However, the study unexpectedly found alarming storage inconsistencies and patient nonadherence to storage guidelines for these drugs.

Rituximab has been successfully used “off label” to treat diseases driven by B-cell dysregulation, but concerns remain about the safety of using rituximab or similar agents for long periods.

On Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on and recommended a marketing authorization for Mylan and Biocon’s Semglee, an insulin glargine follow-on that will be available in the European Union as a solution for injection for patients with diabetes.

In total, income from Biocon’s biologics division was down 15% for the quarter (compared with the same period for the company’s prior financial year), despite the fact that product sales grew 16% year over year, with increased sales of insulins and biosimilar antibodies. The company’s total net profits declined by 46%.

Healthcare spending for the Medicaid expansion population increased steadily over time for beneficiaries who remained enrolled in Medicaid, according to a new analysis from Avalere Health. The analysis also found that spending for prescription drugs increased over the study period, with pharmacy costs (excluding prescription drug claims for hepatitis C treatments) almost doubling over the 2.5-year time period during which the cohort was tracked

This week, the FDA announced that it has issued a direct final rule that amends the biologics regulations to remove what it calls “outdated requirements” and help to eliminate inconsistencies and duplicative processes.

Zarxio, a biosimilar filgrastim approved in the United States in 2015, was demonstrated to have no clinically meaningful differences from its reference in a randomized clinical trial setting, but data on its effectiveness in preventing febrile neutropenia (FN) a real-world setting have been limited thus far.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 22, 2018.

Multiple drug makers are in the process of developing biosimilar candidates to challenge the brand-name Erbitux’s sales.

A study published yesterday in Cancer Chemotherapy and Pharmacology reports that pharmacokinetic (PK) and pharmacodynamic (PD) data from a randomized, double-blind, phase 3 clinical study show similarity between mAbxience’s proposed rituximab biosimilar, RTXM83, and its reference, MabThera, using a population PK model approach.

Although some studies have demonstrated an increased risk of death in patients with inflammatory bowel disease taking corticosteroids, the relationship between death and anti–tumor necrosis factor (anti-TNF) drugs has not been as clear.

At the American College of Rheumatology (ACR)'s Winter Rheumatology Symposium, held this week in Snowmass Village, Colorado, rheumatologists from across the country gathered to discuss the latest approaches to treating rheumatoid arthritis (RA).

Pfizer announced today that PF-05280586, the company’s proposed biosimilar to reference rituximab (Rituxan, MabThera), has been shown to be equivalent to the reference in overall response rate for the first-line treatment of patients with CD20-positive, low tumor burden follicular lymphoma.

Three drug developers have made recent strides forward with their biosimilars or proposed biosimilar referencing Enbrel (etanercept), with new product approvals, manufacturing developments, and growing sales.

The European Medicines Agency (EMA) has launched a survey of pharmaceutical companies to assess their preparedness for the United Kingdom’s upcoming withdrawal from the European Union, as it hopes to identify any concerns about the continued supply of drugs during the Brexit transition.

The report from Trinity Partners details findings from qualitative research with 10 medical directors at US payer organizations, representing plans covering over 100 million commercial and Medicare enrollees in the United States.

In an observational study conducted in Germany that began after the marketing authorization was received for reference trastuzumab in early breast cancer (EBC), researchers were able to analyze outcomes for patients treated with trastuzumab both with and without cytotoxic treatment.