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Study findings in patients with rheumatoid arthritis (RA), write the authors, suggest “that potentially more aggressive treatment is needed across the entire population of patients with RA."

Among the features of the Part D structure is a federal reinsurance program in which, when a beneficiary reaches the catastrophic threshold in a given year, the government subsidizes 80% of remaining spending for the year. Part D plans pay 15%, and patients pay 5% in this scenario.

Clinical developments, policy news, and pharmaceutical business updates ranked among our most popular conference stories of 2019.

AstraZeneca and Daiichi Sankyo said Monday they received FDA approval for their [fam-] trastuzumab deruxtecan-nxki, which will be marketed as Enhertu. [Fam-] trastuzumab deruxtecan is an antibody–drug conjugate (ADC) designed to delivery cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor payload and a tetrapeptide-based linker.

At 6 months and 1 year, respectively, survival rates among the suboptimal responders who stayed on their index anti–tumor necrosis factor (anti-TNF) agent were 90.2% and 85.1%, respectively.

It has been hypothesized that metalloproteinases, and particularly MMP3, could a have a role in degrading anti–tumor necrosis factor drugs, leading to treatment failure in patients with inflammatory bowel disease (IBD).

Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.

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

The World Health Organization (WHO) this week prequalified its first biosimilar. The product, Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, referencing Herceptin, could now become available to more patients with HER2-positive cancer in low- and middle-income countries.

Amgen and Allergan submitted a Biologics License Application (BLA) to the FDA for ABP 798, a biosimilar rituximab referencing Rituxan.

Using a biosimilar can produce substantial cost savings in patients who are receiving infliximab therapy for inflammatory diseases like rheumatoid arthritis (RA), but dose escalations, which are frequent for those who use infliximab, can increase the cost of therapy, even with a biosimilar.

The promise of biosimilars is that these subsequent-entry products can reduce the cost of biologic therapy by offering lower-priced alternatives that do not compromise efficacy or safety. An additional benefit is that the presence of competition in the marketplace can also drive down costs for originator products, or at least curb price growth, though to what degree biosimilars have had such an impact on originator biologics in the US market has not been fully elucidated.

A federal appeals court Wednesday struck down the individual mandate—the heart of the Affordable Care Act (ACA) that requires everyone to have health coverage—and sent the case back to the federal district court in Texas to determine whether other parts of the law are constitutional and can exist without the mandate.

Previously, such chemically synthesized polypeptide products were excluded from the regulatory transition, so subsequent-entry products referencing these drugs would not be eligible for biosimilars or interchangeable product approval. Such products would also not be eligible for generic drug development.

Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price—but different NDCs will not be available for use by biosimilar manufacturers.

This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.

The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.

No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.

Pfizer gained FDA approval for its biosimilar trastuzumab, Trazimera, in March 2019, and is slated to launch in the United States on February 15, 2020. Ahead of that milestone, researchers last week reported long-term safety and overall survival (OS) data for the Herceptin biosimilar in patients with HER2-positive metastatic breast cancer.

Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.

In May of 2018, drug maker Lupin announced that the European Medicines Agency would review its application for YLB113, a proposed etanercept biosimilar referencing Enbrel. This week, results of a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA) revealed the similarity of the product with its reference, and also demonstrated that the product has lower immunogenicity than the reference drug.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.

Outlook Therapeutics, formerly known as Oncobiologics, said this month that it has reached an agreement with the FDA on 3 special protocol assessments for clinical trials of ONS-5010, a formulation of bevacizumab intended to treat retinal diseases.

On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA.

Alberta became the most recent Canadian provincial government to mandate a nonmedical switch to biosimilars for certain patients on taxpayer-funded drug plans.

The Center for Biosimilars® recaps the top stories for the week of December 9, 2019.

The House of Representatives, on Thursday, voted 230-192 to pass Speaker Nancy Pelosi’s, D-California, HR 3, the Elijah E. Cummings Lower Drug Costs Now Act, although the White House has already said it will veto the measure, assuming it is ever brought to the Senate floor and passes.

Given the availability of biosimilars of infliximab, etanercept, and adalimumab in multiple markets worldwide, and given the cost savings associated with the biosimilars, there is growing interest in switching patients receiving maintenance treatment for uveitis to these biosimilar options, but data in switching patients with uveitis have been limited.

During this week’s annual meeting of American Society of Hematology, researchers from Canada reported that using biosimilar filgrastim could result in substantial savings.

Organizations are releasing patient education materials about what biosimilars are, what questions patients should ask, and other things they might want to know. The latest such example comes from Susan G. Komen, which recently released a guide to using biosimilars and biologics for breast cancer.