News

Green Shield Canada (GSC), a not-for-profit health benefits company that offers employee group health benefits that supplement government-sponsored provincial health plans, has announced a new program to switch patients to biosimilar therapies.

Anti–tumor necrosis factor (anti-TNF) treatment has revolutionized the management of ankylosing spondylitis (AS), but 20% to 30% of patients discontinue treatment due to failure or inadequate response to treatment. That being said, anti-TNF therapies are structurally different and have different mechanisms of action; consequently, unsuccessful treatment with 1 anti-TNF drug does not determine a patient’s potential response to another.

Merck, operating under the trade name MSD in the European Union, announced today that it has launched Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, in the United Kingdom.

Gillian Woollett, MA, DPhil, senior vice president of Avalere and leader of the company’s FDA practice, told The Center for Biosimilars® in an interview that a study she co-authored is aimed at reassuring all biosimilar stakeholders that, “even though no clinical differences are expected when patients are switched from a reference product to a biosimilar, indeed none are found. Hence, we confirm the expectation already established through the application of sound regulatory science.”

The Complete Guide to Monoclonal Antibody and Granulocyte-Colony Stimulating Factor Biosimilars Approved in the United States and European Union

“You can’t have your cake—or in this case, your rebates—and a vibrant market for biosimilar competition too,” said FDA Commissioner Scott Gottlieb, MD.

A recent study analyzed the long-term efficacy and safety profile of anti–tumor necrosis factor (anti-TNF) treatment in 15 patients with rhupus, a rare association defined by the coexistence of both systemic lupus erythematosus and rheumatoid arthritis (RA) in the same patient.

Among commercial plans covering employees and their families, said Express Scripts, drug spending increased by just 1.5% per person, down from 3.8% in 2016. Calling this rate a “historic low,” Express Scripts said that this level of spending growth is the lowest that it has measured since 1993.

The trastuzumab biosimilar is priced 29.5% below the list price for the trastuzumab reference product, Herceptin.

To determine whether a course of 300 ug of filgrastim, administered daily for 2 days, achieves the same clinical outcomes that have been reported with the recommended dosage, and whether such a dose could provide cost savings, investigators from Marshall University performed a retrospective chart review to identify all patients at their institution with chemotherapy-induced neutropenia who were treated with 2 consecutive doses of 300 ug of filgrastim between September 2011 and September 2016.

The law, which was passed with broad bipartisan support in both the Michigan House and Senate, allows for biologics designated by the FDA as interchangeable to be substituted at pharmacies with appropriate communication of the substitution to both patients and physicians.

On March 2, UK Prime Minister Theresa May delivered a speech on the future of the United Kingdom’s relationship with the European Union, calling for the United Kingdom to remain a member of the European Medicines Agency (EMA), and saying that the United Kingdom could commit to abiding by the rules of the EMA and “making an appropriate financial contribution” to the agency.

In an effort to evaluate whether switching from a reference biologic to a biosimilar could lead to altered clinical outcomes—such as enhanced immunogenicity, compromised safety, or reduced efficacy—a research team, led by Hillel Cohen, PhD, conducted a systematic literature review of all available switching studies.

The proposed biosimilar references Genentech’s Pulmozyme, a biologic first approved in the early 1990s in both the European Union and the United States. Pulmozyme is used in conjunction with other therapies to improve pulmonary function in patients with cystic fibrosis.

This week, Amgen announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a label variation for its reference pegfilgrastim to now include the branded Neulasta Onpro Kit.

The Canadian Agency for Drugs and Technologies in Health, the Canadian entity responsible for health technology assessments, has announced that it has revised its approach to reviewing biosimilars.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 26, 2018.

The FDA and the European Medicines Agency announced today that the mutual recognition agreement on good manufacturing practice (GMP) inspections between the European Union and the United States now includes 4 additional EU member states.

India-based drug manufacturer Cadila Healthcare has announced that it is planning to file a Biologics License Application (BLA) for its biosimilar pegfilgrastim with the FDA by the end of 2019. To date, no developer has been successful in gaining regulatory approval in the United States or European Union for a biosimilar of the reference pegfilgrastim.

Treatment with rituximab plus a regimen of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) for patients with diffuse large B-cell lymphoma (DLBCL) has proven efficacy in clinical trials, few long-term data are available for the use of this combination in patients in a real-world setting.

Richard G. Frank, PhD, a health economist at Harvard Medical School and the former deputy assistant secretary for planning and evaluation at HHS, has penned a new perspective paper in the New England Journal of Medicine in which he warns that, if biosimilars continue their trajectory, they could fail to deliver on their promise to provide cost savings to the US health system.

Virginia’s House and Senate have both passed a new bill, HB1177, which prohibits PBMs from penalizing pharmacists for sharing drug pricing information with consumers.

February 2018 saw a number of developments for biosimilars that treat inflammatory bowel disease, with new studies from around the globe adding to the body of data on these therapies.

In a recently published editorial in The Official Journal of the World Federation of Hemophilia, author Angela Thomas, MB, PhD, discusses the advancements in hemophilia treatment as well as the place biosimilars may or may not have in reducing the cost of care.

The American College of Rheumatology (ACR) has updated its health policy statements for 2018, and biosimilars featured heavily in the organization’s concerns for the year ahead.

Because tumor necrosis factor-alfa (TNF) has been identified as possessing tumor-promoting properties in multiple malignant tumors, anti-TNF therapies have been proposed as a potential combination treatment that could enhance the effects of chemotherapy in patients with colon cancer.

A recently published editorial linked to a previous switching study for patients who had been receiving reference infliximab (Remicade) to biosimilar infliximab (Inflectra) argues that the positive results of the trial “apparently settles the case in favor of unrestricted switching of 'expensive' originator to 'cheap' biosimilar infliximab. Yet, the devil is the details."

Over the past 2 years, commercially insured patients enrolled in plans that had value-based contracts for certain high-cost drugs had lower copays for their medications than did patients enrolled in plans without such contracts. That finding comes from “Delivering Results for Patients: The Value of Value-Based Contracts,” a new report from the Pharmaceutical Research and Manufacturers of America (PhRMA).

The US Patent Trial and Appeal Board (PTAB) has decided that the Saint Regis Mohawk Tribe cannot claim sovereign immunity from inter partes review (IPR) of Allergan’s patents covering Restasis, and that the IPR proceedings on those patents can continue with Allergan as the patent owner.

On Thursday, JHL Biotech, a biopharmaceutical startup based in Taiwan, announced that the Bulgarian Drug Agency has approved a phase 1 clinical trial application of a proposed bevacizumab biosimilar, JHL1149.