News

The Institute for Clinical and Economic Review (ICER) has issued its first annual report on unsupported price increases for US drugs. The report found that 3 brand-name biologics that have FDA-approved biosimilars—adalimumab, rituximab, and pegfilgrastim—have had significant price increases that were not supported by new clinical evidence.

A recent preliminary study examined whether adults treated with anti–tumor necrosis factor agents (anti-TNFs) had reduced the risk of Alzheimer disease, and found that patients with rheumatoid arthritis (RA) and psoriasis who were treated with anti-TNFs had a lower risk of developing the incurable neurocognitive disorder.

Even as biosimilars of anti–vascular endothelial growth factor (anti-VEGF) agents are coming to market and advancing through the pipeline, a new agent that may have substantial benefits for patients with wet age-related macular degeneration (AMD) has been approved by the FDA: brolucizumab, which sponsor Novartis will sell as Beovu.

The FDA has issued a complete response letter for Tanvex BioPharma’s TX01, a proposed biosimilar filgrastim referencing Neupogen.

The state’s Department of Health and Human Services this week sent letters to firms that did not provide required information about production costs, marketing and advertising costs, patient assistance programs, wholesale acquisition costs, and historical increases, among other information.

According to the authors, while many anticipated that most major concerns about the switch to biosimilar adalimumab would relate to safety and efficacy, more prevalent concerns were related to device type, the presence of a citrate, or the color of the product.

The FDA has approved Pfenex’s follow-on teriparatide, PF708, referencing Forteo, for the treatment of osteoporosis in patients at high risk for fractures.

Biosimilar developer Celltrion and Juno Pharmaceuticals announced that they have entered into a comarketing partnership for Celltrion’s trastuzumab biosimilar, Herzuma, and its rituximab biosimilar, Truxima, in the Australian market.

The Labour party, the United Kingdom’s official opposition party, revealed during a conference that it plans to reduce the cost of drugs by setting up a government-owned generic drug manufacturer that would supply medicine to the National Health Service and by employing compulsory licensing to use drug makers’ intellectual property to develop generics.

This week, the White House has been signaling that it sees progress on the problem of high drug prices, a subject of such concern to the administration that it released the “American Patients First” blueprint for reducing drug prices in 2018. However, some groups are calling for redoubled efforts on encouraging biosimilars as a way to generate savings and relieve the burden of high drug costs on the healthcare system and on patients.

President Donald Trump has signed an executive order on improving Medicare.

The Center for Biosimilars® recaps the top stories for the week of September 30, 2019.

There are some health policy experts who believe that price transparency will work to bring down healthcare spending. In a recent article in JAMA, Gilbert Benavidez, MPH, and Austin Frakt, PhD, say that the notion has rarely worked, but they suggest there are 2 ways that it might.

Could adalimumab and its biosimilars become a less attractive option for treating some inflammatory diseases in the face of new therapeutic choices like interleukin-17 inhibitors? In the case of ixekizumab, a recent head-to-head study versus adalimumab showed that the newer product was superior in terms of improving joint and skin disease in patients with psoriatic arthritis.

Biocon and Mylan have launched their biosimilar insulin glargine, Semglee, in Australia. The general schedule for Semglee lists the biosimilar as “a-flagged,” a designation that allows a product to be substituted at the pharmacy level without consulting with the prescribing physician.

The case over whether drugmakers can be compelled to disclose pharmaceutical prices in direct-to-consumer (DTC) television advertisements continues in the US Court of Appeals for the District of Columbia, with HHS appealing and AARP and the AARP Foundation filing an amicus brief this week in Merck & Co. Inc. et al v US Department of Health and Human Services et al.

Drug maker Novartis announced that it will seek a fourth indication—nonradiographic axial spondyloarthritis (nr-axSpA)—for its secukinumab (Cosentyx) in the United States after its phase 3 PREVENT trial met its 52-week primary end point.

A newly introduced item of legislation proposes to eliminate co-payments for patients when they receive a biosimilar rather than an originator biologic in Medicare Part B.

Step therapy, which requires that patients try the payer’s preferred treatment before the one a physician recommends, jeopardizes the health of patients with cancer by delaying treatment and creating unnecessary barriers, according to a recent position statement from the Community Oncology Alliance (COA).

While policy makers have hailed drug price transparency laws as steps toward bringing down the high cost of drugs for US patients, questions remain as to how effective these laws are at achieving their aims. Now, in a research letter published in JAMA Network Open, researchers say that these laws are largely ineffective at revealing true transaction prices for drugs.

Biosimilar trastuzumab is becoming a feature of the biosimilar landscape in both Europe and the United States, with 5 agents (Herzuma, Kanjinti, Ontuzant, Ogivri, and Trazimera) approved in both territories and with additional biosimilars in the drugmakers’ pipelines. During the European Society for Medical Oncology (ESMO) Congress 2019, held in Barcelona, Spain from September 27 to October 1, researchers reported new data from phase 3 studies of 2 such biosimilar products.

The FDA has approved another indication for reference rituximab (Rituxan), this time for children with rare vasculitis diseases.

Using data compiled for BiologicsHQ.com, we analyzed 2 bills that propose changes to patent litigation by limiting the number of patents a reference product sponsor can assert in a patent litigation to see how many biosimilar cases they would have impacted so far and whether they would really help bring biosimilars to market sooner.

During the European Society for Medical Oncology (ESMO) Congress 2019, researchers provided a detailed look at a 3-treatment, 6-sequence crossover study for a pegfilgrastim biosimilar, and a separate team presented on the use of biosimilar filgrastim in patients who are being given chemotherapy regimens that involve a rest period of up to 14 days.

In an email to The Center for Biosimilars®, a Pfizer representative said that, after having agreed to the terms of a settlement with Genentech and Roche that provides the biosimilar developer with global licenses for its product, Pfizer plans to launch its biosimilar bevacizumab, Zirabev, in the US market on December 31, 2019.

With the US Congress back from its summer recess, September marked a busy time on Capitol Hill for policy proposals that touch on drug pricing, biosimilars, and patient access to high-cost therapies.

During this week’s European Society for Medical Oncology (ESMO) Congress 2019, held September 27 to October 1 in Barcelona, Spain, a research team presented findings from a phase 3 trial of Samsung Bioepis' SB8, a proposed bevacizumab biosimilar referencing Avastin.

The bill would amend the Employee Retirement Income Security Act to require group health plans to provide an exception process for step therapy so that patients can access treatment without delays.

The Center for Biosimilars® recaps the top stories for the week of September 23, 2019.

A report out this week from the House Ways and Means Committee details the extent to which Americans pay more for drugs than other countries—nearly 4 times as much, in fact.