News

Ontruzant, a biosimilar trastuzumab referencing Herceptin, shows comparable overall survival and cardiac safety, Samsung Bioepis says.

The Center for Biosimilars® recaps the top news for the week of March 18, 2019.

As he wraps up his final weeks as commissioner of the FDA, Scott Gottlieb, MD, talked about the factors holding back biosimilars in the United States.

Some stakeholders raised questions about how orphan drugs or biosimilars would be analyzed in the report. The Institute for Clinical and Economic Review's (ICER's) response to both were similar: it did not understand why drugs for orphan diseases or the market entry of biosimilars would lead to rapid price increases.

Like all biologics, infliximab has the potential for immunogenicity, and the development of antidrug antibodies (ADAs) can lead to loss of response or hypersensitivity reactions. A newly published paper sought to evaluate the development of a cellular response to infliximab and whether such a response could predict ADA development.

The European Commission has approved Roche’s innovator rituximab, sold in Europe as MabThera, for the treatment of pemphigus vulgaris (PV), a rare autoimmune disorder. The approval marks the first biologic approval for PV in the European Union, and the first major new therapeutic option in 60 years.

Branded drug products have fewer potential cost-saving limits on them in Medicare Part D formularies, researchers at John Hopkins University have found.

The Biosimilars Forum and Medicines for Europe today released a joint white paper that discusses how Europe has successfully sustained its multisource biosimilars market for the past 10 years. The forum also suggests that the United States make structural changes in order to achieve similar success.

The FDA maintained its requirement that all newly licensed biologics include a 4-letter suffix to distinguish each product, and even extended this requirement to interchangeable biosimilars. This provision, among others, has stoked concerns in the biosimilars industry and in many circles concerned about lowering drug costs.

A class action lawsuit has been filed by United Food and Commercial Workers Local 1500 (UFCW Local 1500) against AbbVie for alleged use of a patent thicket to maintain a monopoly for its brand-name adalimumab, Humira. The complaint also alleges that AbbVie and a number of its biosimilar competitors colluded to divide the market for adalimumab between Europe and the United States.

The administration said the update to the dashboards is part of its effort to improve transparency around drug pricing; the administration also wants to shift some Part B coverage to Part D as part of its plan to reduce total drug spending, with the idea that Part D plan sponsors would have more negotiating room with pharmaceutical companies.

Although rituximab does not carry an indication for the treatment of neurological disorders, the drug is widely used off-label as a therapy for B-cell–mediated disorders like multiple sclerosis (MS). Given the fact that rituximab has not been approved in these indications, however, data that reflect its safety and efficacy—particularly in patient populations for whom data are particularly scarce—are crucial.

In a paper published last week in ACR Open Rheumatology, researchers reported that although patients had some concerns about safety and efficacy, overall, they were satisfied with the switch to a biosimilar.

Sagent Pharmaceuticals, a division of Nichi-Iko Pharmaceutical Co Ltd, announced earlier this month that it has purchased an FDA-approved manufacturing site in Raleigh, North Carolina, from Xellia Pharmaceuticals.

This week, Novartis announced that Richard Francis, chief executive officer (CEO) of the company’s Sandoz division, will step down on March 31.

According to the investigators, their data support the further development of CT-P16 as a bevacizumab biosimilar.

The Center for Biosimilars® recaps the top news for the week of March 11, 2019.

The United Kingdom’s Competition and Markets Authority has closed an investigation into an alleged anticompetitive discount scheme related to brand-name infliximab, Remicade.

The new acting chief of the FDA, Ned Sharpless, MD, has a track record with the biotechnology industry and a friendly relationship with the man he is replacing, Scott Gottlieb, MD.

Recently, a new study sought to examine treatment patterns in US patients new to anti–tumor necrosis factor (anti-TNF) therapy, and it found that a majority of patients, particularly women, do not remain on their first anti-TNF after 2 years.

On Wednesday, the House Committee on Energy and Commerce held a Health Subcommittee legislative hearing on lowering the cost of prescription drugs. The 7 bills that were the subject of the hearing include several items of legislation that have long waited for congressional action as well as new proposals to address the need for increased competition.

Patients using expensive specialty medications, such as those that treat inflammatory diseases, are particularly impacted by pharmacy benefit manager (PBM) rebates, given the relationship of rebates to price. In the case of biosimilars, rebate strategies may lead to reference biologics being placed on preferred formularies in the United States while less expensive options are kept off the formulary.

Drug maker Alvotech announced today that it has begun enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira. Alvotech says that it has enrolled its first patient, and it plans to enroll approximately 400 total participants at 30 European sites in the study of AVT02 versus the reference product in patients with chronic plaque psoriasis.

The FDA has issued a new Form 483 to Biocon over the Bangalore facility where it produces its biosimilars. The document makes 2 inspection observations that stem from an inspection carried out in February 2019.

A recent meta-analysis of reference filgrastim’s (Neupogen) role in chemotherapy since its approval in 1991 shows how the definition of value has evolved over time as biosimilars for granulocyte colony-stimulating factors (G-CSF) entered the market.

The Trump administration has released its proposed budget for the fiscal year 2020, and contained within it are a variety of proposals that impact biosimilars.

Among the data presented to regulators for the product’s approval were those arising from a phase 1 pharmacokinetic and pharmacodynamic study in healthy volunteers and those from 2 phase 3 studies in patients with breast cancer undergoing chemotherapy.

The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin.

A survey of health plan benefit sponsors representing employers found that most are using prior authorization (PA) or step therapy to encourage the use of biosimilars, but fewer are considering mandatory switching, cost-sharing differentials, or higher cost-sharing for reference biologics for new patients, according to a report from The Pharmacy Benefit Management Institute.

Only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia–Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.