News

Regeneron’s aflibercept (Eylea) has been approved by the FDA for a prefilled syringe (PFS) presentation. The 2-mg, single-dose, PFS will offer the greater ease of use less preparation than the vial presentation of the drug used to treat a range of eye disorders.

This week, a pair of papers detailing the clinical program for the biosimilar appeared in Pharmacology Research and Perspectives.

Concerns about overseas inspections continue in the wake of an HHS plan to create 2 potential pathways to allow the importation of some drugs that were intended for foreign markets.

This month, researchers published data from a phase 3 study of the biosimilar in patients with moderate to severe rheumatoid arthritis (RA) after previous phase 3 data were reported for a study in patients with severe plaque psoriasis.

Instead of the “totality of the evidence” approach to biosimilars, authors of a new paper propose a “confirmation of sufficient likeness” paradigm.

A recent article described a quality improvement project at the oncology specialty pharmacy unit within the University of Chicago Medicine.

The Canadian government has announced amendments to its regulations concerning patented drugs that it says will make medicines more affordable. According to Health Canada, these changes will save Canadians $13.2 billion (US $9.97 billion) over the next decade.

A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi.

Among the patients who viewed positively framed video explanations of biosimilars, 67% were willing to switch.

Winnie Tiedemann, 73, of New Jersey lives with her son and his 5 children. Tiedemann was diagnosed with diabetes at age 25 and has been insulin-dependent for the past 20 or so years. Her out of pocket costs for insulin? Around $3600 a year.

The study was conducted in patients with moderately to severely active rheumatoid arthritis who previously completed the VOLTAIRE-RA study.

A panel of judges for the United States Court of Appeals for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.

There remain many uncertainties and questions around the success of these agents. It is therefore critical for sponsors and other stakeholders to consider some of the potential hurdles and policy shifts facing anticancer biosimilar uptake and ultimately reimbursement in the United States.

The Center for Biosimilars® recaps the top stories for the week of August 5, 2019.

The August issue of JAMA Oncology features a Viewpoint that puts forth a free-market solution to lower high drug costs by changing dosing regimens without hurting efficacy using the approach of interventional pharmacoeconomics (IVPE).

OneOncology, a national partnership of community oncology practices, says that its partner practices have begun treating patients with 2 anticancer biosimilars: Kanjinti, a trastuzumab biosimilar referencing Herceptin, and Mvasi, a bevacizumab biosimilar referencing Avastin.

In its semiannual drug pricing forecast, healthcare performance company Vizient said that biosimilars will be a key part of combatting rising spending on drugs among its membership.

Anti–tumor necrosis factor medicines are one of the costliest drugs for many health systems, and in the United Kingdom, a recent article described how one clinical commissioning group managed the switch of patients on the originator etanercept (Enbrel) to a biosimilar (Benepali) using a fixed-price model.

The International Generic and Biosimilars Medicines Association (IGBA), which represents generic and biosimilar medicines associations worldwide, recently released its report on how trade agreements can foster generic and biosimilar medicines and improve patient access to care.

A study published this month proposes that biosimilars be assessed in a quantitative benefit-risk analysis to assess whether what the authors call “uncertainty in the clinical performance of biosimilars” can be countered by lower pricing.

Not everyone shares the view that authorized generics are a boon, and concerns are rising that the marketplace may soon see the advent of authorized biologics.

The retrospective analysis of practice care delivery measures at Memorial Sloan Kettering Cancer Center showed substantial time savings for both patients and the healthcare system, researchers report.

Samsung Bioepis’ etanercept biosimilar, SB4, has been available in multiple markets since it was authorized by the European Commission in 2016, and this week, a new systematic review reported on real-world evidence on the use of the biosimilar in treating inflammatory diseases.

The fact sheet is being released as Canada awaits the launch of additional anticancer biosimilars.

Since Democrats control the House, Speaker Nancy Pelosi, D-California, is a major factor in determining how fast this agreement moves through Congress. One of the major Democratic points of concern is how prescription drugs, namely biologics, are handled in the USMCA.

Biosimilar earnings were due in large part to the European launches of biosimilar trastuzumab (Kanjinti) and biosimilar adalimumab (Amgevita), which Amgen said are progressing in line with expectations and annualizing at more than $300 million.

According to Momenta, the decision is a result of “changes in the market opportunity associated with Humira patent litigation settlements.”

Mylan and Biocon announced this week that they have launched their biosimilar trastuzumab, Ogivri, in Australia. Ogivri, referencing Herceptin, is the first trastuzumab biosimilar to launch in the Australian marketplace and is listed on the nation’s Pharmaceutical Benefit Scheme.

Will biosimilars improve public health? Policy makers should look to that question as they sort through possible solutions, the authors say.

The Center for Biosimilars® recaps the top stories for the week of July 29, 2019.