News

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.

A pair of studies appearing in The New England Journal of Medicine report on 2 separate studies of biologics in patients with moderate-to-severe ulcerative colitis: One study confirms top-line results seen earlier this year in a head-to-head study of vedolizumab and adalimumab, and the other reports on the results of a single intravenous infusion of ustekinumab followed by subcutaneous maintenance injections.

As a company with a 4-decade legacy of delivering innovative biologics to patients, and an equally fervent commitment in biosimilars (3 approved and 2 launched in the United States, with many more in our pipeline), Amgen understands that patient, physician, pharmacist, and payer confidence in the regulatory approval process is a critical factor to the long-term success of the US marketplace with biosimilars. We strongly believe appropriate clinical testing must be included in the regulatory approval process for biosimilars.

A small investor who currently holds 20 shares of Allergan has filed a proposed securities class action lawsuit seeking to stop its purchase by AbbVie, according to reports.

This month, 2 biosimilar developers announced expansions of their research and development (R&D) capacities with the acquisition of new sites.

This month, Elena Wolff-Holz, MD, PhD, chair of the European Medicines Agency’s (EMA’s) Biosimilar Medicinal Products Working Party, together with coauthors from the EMA and the Federal Institute for Drugs and Medical Devices in Germany, published a new paper in which the team outlines the extent of clinical confirmation of biosimilarity, taken together with analytical and functional data, that is considered necessary for biosimilar drugs to be approved in Europe.

Today, the FDA released a new suite of resources to educate patients about biosimilars.

Two biosimilar bills, both with bipartisan sponsors, were unveiled last week and aim to boost uptake in the United States, one through increased Medicare payment and the other via additional education.

During last week’s 22nd Annual Meeting of the Chinese Society of Clinical Oncology, held from September 18-22 in Xiamen, China, drug maker Innovent Biologics presented updated results for its proposed bevacizumab biosimilar, IBI305, in an oral session.

During its September 2019 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a change to Celltrion’s marketing authorization for its biosimilar infliximab, CT-P13, sold in Europe as Remsima.

While rituximab does not carry indications for the treatment of multiple sclerosis (MS) or aquaporin-4-positive (AQP4) neuromyelitis optica spectrum disorder (NMOSD), the CD20-depleting therapy and its biosimilars are commonly used off-label, as the therapy has been demonstrated to be effective in reducing relapses in MS as well as in reducing the frequency and severity of attacks in NMOSD.

This week, Russian drug maker Generium announced that it has received approval for—and has launched—its biosimilar dornase alfa in the Russian marketplace. Generium’s product is the first biosimilar dornase alfa biosimilar to be approved in any market worldwide.

The FDA this week finalized industry guidance intended to stop citizen petitions used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

A team of authors points out that, given batch-to-batch variation of all biologics that can be enhanced by manufacturing changes, no batches of biologics can be considered identical to one another. However, “they may be considered essentially equal and therapeutically indistinguishable,” which points to a clinically acceptable range of structural heterogeneity for any biologic.

The Center for Biosimilars® recaps the top stories for the week of September 16, 2019.