News

The improved efficacy of a biologic drug in combination with a conventional treatment in rheumatoid arthritis (RA) has been well demonstrated, but some biologic-naive patients are unable to tolerate drugs such as methotrexate. Limited data are available about which biologic to select for monotherapy in such patients, however.

On September 13, the European Medicines Agency (EMA) published new, patient-focused materials that aim to make patients aware of biosimilar medicines and how the EMA assures that they are as safe and effective as reference biologics.

Rituximab-based immunochemotherapy can be safely applied in patients after obinutuzumab-associated anaphylaxis, but the existing risk of cross­reactivity should be considered, and careful monitoring of such patients during rituximab infusion is required.

This week, Boehringer Ingelheim announced results from a 16-week phase 3 study that confirmed biosimilar adalimumab-adbm (to be sold as Cyltezo) was clinically equivalent to the reference product, Humira.

Up to 60% of Crohn disease patients taking an anti—tumor necrosis factor (TNF) monoclonal antibody medication eventually stop responding to treatment, but the optimal management of these patients has not been clearly defined.

The Center for Biosimilars® recaps the top news for the week of September 10, 2018.

A new study suggests that CD8+ natural killer cells are a biomarker that can predict therapeutic outcome for patients with ankylosing spondylitis who are administered anti–tumor necrosis factor agents because they are nonresponsive to conventional treatment.

Adherence and persistence rates for biologic drugs are still low in the United States, leading to suboptimal patient outcomes and putting a substantial burden on the healthcare system.

Only 38% of Americans say that they are either very confident or somewhat confident that the administration’s plan will result in paying less for their prescription drugs.

Two pivotal studies of biosimilar epoetin alfa (Retacrit) versus its reference (Epogen) in patients undergoing hemodialysis have shown that the biosimilar and the originator have comparable safety and efficacy. In the phase 3b PIEDA (Phase 3b Investigation of Erythropoietin Drugs Using a Specified Dosing Algorithm) study, investigators sought to further investigate how switching from the reference to the biosimilar affects maintenance of hemoglobin levels when using an erythropoiesis-stimulating agent dosing algorithm.

Korean drug maker Celltrion says that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will convene to discuss the Biologics License Application (BLA) for CT-P10, a proposed biosimilar rituximab, on October 10, 2018. CT-P10 is already authorized in the European Union, where it was approved under the trade names Rituzena, Ritemvia, Truxima, and Blitzima.

The National Institute for Health Research's Clinical Research Network maintains an active list of more than 800 clinicians—practicing in oncology, gastroenterology, endocrinology, and dermatology—who are interested in delivering trials of biosimilar medicines.

Xbrane’s lead biosimilar candidate is a ranibizumab product (referencing Lucentis), developed in collaboration with Stata, that is moving into a pivotal clinical trial. The study will enroll patients with wet age-related macular degeneration across 16 countries.

Since its inception, one of the best features of public and private Medicare Part B has been that patients are able to access their treatments without delay. That’s why healthcare providers, in collaboration with the patient, should be the primary treatment decision-makers. “Fail-first” policies prevent patients from receiving the right medication at the right time, and seniors can’t live with delays or risk disease destabilization.

“Biosimilars offer incredible health and economic opportunities in the United States, but unless substantial barriers are surmounted, these opportunities will not be fully realized,” say the report's authors.

While both the biosimilar filgrastim and biosimilar pegfilgrastim were effective in reducing the incidence of neutropenia, adverse events related to granulocyte-colony stimulating factor therapy were significantly higher in patients who received pegfilgrastim.

The Center for Biosimilars® recaps the top news for the week of September 3, 2018.

The European Union already has far more approved biosimilars—45 products referencing 15 medicines—than does the United States, but as a newly released report from IQVIA states, the number of European biosimilars available today represents just a fraction of what the market is expected to contain in the coming years, raising questions about the sustainability of the market.

Writing in the European Medical Journal, Anna La Noce, MD, PhD, and Marcin Ernst, MD, MBA, explain that much confusion about switching between biosimilars and reference products in the United States versus in the European Union arises from different uses of the term “interchangeability.”

Two research letters, published concurrently in the Journal of the American Medical Association, focused on biosimilars and their role in the Medicare population.

Currently, UK eligibility criteria for starting biologics in patients with rheumatoid arthritis (RA) set a threshold of a disease activity score in a count of 28 joints of 5.1 or higher—the threshold for severe disease—on at least 2 occasions measured 1 month apart.

Though biosimilars have the potential to provide a less costly option for patients, the products have not seen the uptake in the marketplace that the FDA had expected. This apprehension was reiterated in FDA Commissioner Scott Gottlieb’s comments at the meeting: “I’m not satisfied with the current state of the biologics market and biosimilars in particular.”

Janssen’s drug, sold in New Zealand as Eprex (and in the United States as Epogen) would lose funding after a transition period beginning in February 2019. After the close of the transition, only Novartis’ approved biosimilar, sold as Binocrit, would be eligible for funding in community and hospital settings.

Celltrion announced last week that it has completed its phase 3 clinical trial for subcutaneous biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in other territories as Remsima), and that it will now prepare a marketing authorization application for submission to the European Medicines Agency.

IgG4-related disease (IgG4-RD), a systemic disease that can affect any part of the body and can involve fibrosis, irreversible organ damage, and secondary amyloidosis, is a rare immune-mediated condition often treated with corticosteroids or immunosuppressive drugs. The pathogenesis of the disease is not clear, but treatment with B-cell depletion therapy, in the form of rituximab, has shown positive results in some patients.

Pediatric Crohn disease (CD), which can have serious impacts on children’s growth, is increasing in incidence. Current treatments for pediatric patients with CD—such as corticosteroids or immunomodulators—may be particularly difficult for children to tolerate. Infliximab, however, has been shown to be effective and well tolerated in children, as a newly published phase 3 study in Japanese pediatric patients with CD found that infliximab improved clinical outcome measures from week 2 to week 56.

Regulators licensed the 3 etanercept biosimilars discussed for all of the indications of the reference drug on the basis of the extrapolation of indications, a practice that the authors say rheumatologists may find “anomalous and a source of debate.”

The Trump administration this week announced a preliminary trade deal between the United States and Mexico. Under the agreement, which looks to update the North American Free Trade Agreement, brand name drug makers will receive 10 years of exclusivity for biologics in addition to more products qualifying for this protection.

The Center for Biosimilars® recaps the top news for the week of August 27, 2018.

August 2018 saw a variety of developments in the policy landscape for biosimilars, both in the United States and worldwide.