News

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.

On the same day that House Speaker Nancy Pelosi, D-California, unveiled her plan to lower drug prices by giving the United States the ability for Medicare to negotiate certain drug prices and seek rebates from drug makers if their prices soar above inflation, a new AARP report shows that retail prices in 2017 were 2.1% above the general inflation rate and marked 12 straight years of price increases.

By providing time-saving options for treatment, Roche may be able to secure market share for its innovator biologics if savings in terms of chair time for patients are able to offset the eventual price discounts made available by biosimilar developers for their products.

The FDA requested that Retacrit's maker provide data on subcutaneous administration, given that immunogenicity of a protein can be impacted by route of administration. Results from that study, newly published in Kidney International Reports, show that the subcutaneous administration of the biosimilar has similar safety and efficacy to subcutaneous administration of the reference (Epogen, Procrit).

Premier, Inc. recently released updated inflation estimates for contracted and non-contracted pharmaceutical pricing for fiscal year 2020 and said most of the overall pharmaceutical inflation comes from new drugs (2.8%), including cellular and gene therapies.

Vial sharing for bevacizumab that would otherwise have been discarded yielded a 97.88% reduction in the total cost of a single year of intravitreal injections, as well as a 96.54% increase in the number of injections performed.

The drug maker indicates that, conservatively, it plans to see 60% to 70% erosion for rituximab (Rituxan, MabThera), trastuzumab (Herceptin), and bevacizumab (Avastin) by 2023, leaving a gap of approximately $9.6 billion for the company to fill.

While acknowledging the role that the Orphan Drug Act had in incentivizing drug companies to develop treatments for small populations suffering from rare diseases, America’s Health Insurance Plans (AHIP) says pharmaceutical companies are using orphan drug status to create blockbuster drugs that are then used to treat other common medical conditions.

Sandoz’s biosimilar filgrastim was first approved in Europe in 2009 under the name Zarzio (later, the same drug was approved as Zarxio in the United States). Since that time, the number of biosimilars approved for use in the oncology field has grown substantially, and a recent review says that the past decade of experience with biosimilar filgrastim underscores the strong scientific basis for the extrapolation of indications for biosimilars.

The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a second component of its recent white paper on barriers to biosimilars in the United States; the newly published segment highlights postmarket barriers to biosimilar adoption and says that they have taken a significant toll on the US healthcare system in terms of lost savings.

A recent study says step therapy in rheumatoid (RA) or psoriatic arthritis (PsA) can hurt treatment outcomes.

The United States Court of Appeals for the Third Circuit has sided with Johnson & Johnson (J&J) and its Janssen division, requiring a dispute between the Remicade maker and Rochester Drug Cooperative to be sent to arbitration.

While it is well understood that timely access to treatment is key for the management of rheumatic diseases, respondents to The American College of Rheumatology (ACR) 2019 Rheumatic Disease Patient Survey reported difficulty accessing and paying for their therapies in the past year.

Kaiser Health News, in its latest update to its campaign contributions tracking tool, reports that Senator Chris Coons, D-Delaware, received the most contributions from the pharmaceutical industry during the first half of 2019, at $103,000. Coons, together with Senator Thom Tillis, R-North Carolina, who himself received $102,000 this cycle, released a draft of a patent reform bill in May, and concerns among drug makers about the eventual passage of that bill have run high.

The Institute for Clinical and Economic Review (ICER) said this week it will review the comparative clinical effectiveness and value of therapies for ulcerative colitis, including the reference infliximab product from Johnson & Johnson and biosimilar infliximab from Pfizer.

Samsung Bioepis has launched its biosimilar etanercept, SB4, in Brazil. The biosimilar, which is being sold as Brenzys, was approved in Brazil in 2017 to treat rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and nonradiographic axial spondyloarthritis.

During this week’s meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers are presenting new data for eculizumab in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disorder that typically affects the optic nerves and spinal cord and that can cause significant, irreversible disability.