Kelly Davio

At the American Diabetes Association’s 78th Scientific Sessions, researchers presented ways in which education—for both patients and providers—can help improve the care of patients with diabetes who use biosimilar or follow-on insulins.

Under the agreement, AbbVie will grant Mylan a nonexclusive license to sell its drug in the United States and in other markets outside of Europe. The US license term for the biosimilar will start on July 31, 2023, and Mylan will pay royalties on its sales to AbbVie.

In an email to The Center for Biosimilars®, Mylan confirmed that it will launch its biosimilar pegfilgrastim at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects a 33% discount to the WAC of Amgen’s reference product, Neulasta.

Biosimilars of anticancer monoclonal antibodies are emerging in the therapeutic landscape, and while the body of evidence concerning switching to supportive care biosimilars—epoetin and filgrastim biosimilars—is robust, there are fewer data available concerning a switch to biosimilars of products such as rituximab, trastuzumab, and bevacizumab.

In India, Razumab, manufactured by Intas Pharmaceuticals, was approved as a similar biologic to ranibizumab in 2015; the retrospective study RE-ENACT collected data and analyzed the effectiveness of this biosimilar product in the real-world setting in patients with age-related macular degeneration, diabetic macular edema, and retinal vein occlusion (RVO).

Rheumatoid arthritis (RA) has a considerable economic burden, and costly biologic drugs, including anti–tumor necrosis factor (TNF) agents, are often prescribed in cases in which patients fail to respond adequately to methotrexate.

During the fourth congress of the European Academy of Neurology, held in Lisbon, Portugal, from June 16 to 19, researchers presented on the roles of both existing and investigational anti-CD20 drugs in treating neurological diseases.

Senator Orrin Hatch, R-Utah, has filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples Act, which was advanced to the Senate by the Judiciary Committee on June 14, 2018.

A new study, published in Alimentary Pharmacology and Therapeutics, sought to test antigenic comparability between the reference infliximab and the biosimilar.

Korean drug maker Celltrion has announced that it has resubmitted its Biologics License Application for CT-P6, a trastuzumab molecule referencing Herceptin. Separately, Celltrion announced new data for its proposed subcutaneous formulation of its flagship biosimilar, CT-P13, an infliximab biosimilar referencing Remicade, in patients with rheumatoid arthritis.

Researchers from Spain, where biosimilar use is encouraged as a way to save on costs and expand access to biologic therapies, recently reported on a multicenter prospective observational study in patients with inflammatory bowel disease (IBD) who switched from reference infliximab to a biosimilar, CT-P13 (Inflectra, Remsima).

Rituximab has previously been shown to be effective at doses of 1000 mg in treating patients with rheumatoid arthritis (RA) who had previously received other biologic agents. Research presented at the European League Against Rheumatism's Annual European Congress of Rheumatology demonstrates that using lower doses of biosimilar rituximab—which may provide a substantial cost savings—is also effective.

At the European League Against Rheumatism Annual European Congress of Rheumatology, researchers presented findings on 3 studies in which patients switched to a biosimilar etanercept molecule from the reference Enbrel.

The Senate Judiciary Committee today voted 16 to 5 to report the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act) to the Senate floor.

At the European League Against Rheumatism (EULAR)'s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers reported on Biocad’s Russian-authorized biosimilar infliximab, BCD-055, and on switches to the widely approved infliximab biosimilar CT-P13 (Inflectra, Remsima).

At the European League Against Rheumatism’s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, the patient experience with switching to biosimilars from their reference products is a key topic among stakeholders.

During the European League Against Rheumatism’s Annual European Congress of Rheumatology, researchers published findings on the economic impacts of nonmedical switching; while 1 study found that switching to biosimilar infliximab brought down costs without sacrificing efficacy or safety, but another raised concerns about increases in overall healthcare utilization.

HHS Secretary Alex Azar today testified before the Senate’s Committee on Health, Education, Labor, and Pensions on the Trump administration’s blueprint to lower drug prices.

“I see no reason as a healthcare provider to intentionally go back and forth needlessly, but I see no concerns that, if I do that, bad things would happen,” said Jason Schairer, MD.

Crohn disease (CD) can involve physical, psychological, and social impairments that negatively impact patients’ quality of life, and high levels of anxiety and depression have been observed in patients with CD.

This week, a Delaware District court granted Boehringer Ingelheim’s (BI) motion to compel discovery in AbbVie v Boehringer Ingelheim, an ongoing litigation over adalimumab (Humira).

The question of whether to switch patients from a reference biologic to an available biosimilar has been the subject of extensive debate, especially in patients with inflammatory bowel disease (IBD), an indication in which evidence on relevant clinical outcomes after switching is limited.

During the 2018 American Society of Clinical Oncology Annual Meeting, researchers published new findings on the use of rituximab in mantle cell lymphoma (MCL) as well as the outcomes of patients who relapse early after treatment with rituximab for diffuse large B-cell lymphoma (DLBCL).

Clinical practice guidelines recommend the use of granulocyte-colony stimulating factor (G-CSF) therapies, including the long-acting pegfilgrastim (Neulasta), for the prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy. Real-world data, published in an abstract concurrent with the 2018 American Society of Clinical Oncology Annual Meeting, demonstrate the feasibility of administering pegfilgrastim via an on-body device.

Celltrion presented new research that demonstrates that a formulation of its infliximab biosimilar intended for subcutaneous administration is comparable to the intravenously administered option. The phase 1 study compared the subcutaneous formulation—which can be self-administered—with the FDA-approved intravenous formulation in patients with active Crohn disease (CD).

Research published in conjunction with the 2018 American Society of Clinical Oncology Annual Meeting presented new findings on the use granulocyte-colony stimulating factor agents in treating febrile neutropenia (FN) and in peripheral stem cell mobilization.

The FDA has approved Mylan and Biocon’s pegfilgrastim biosimilar, pegfilgrastim-jmdb. The product, the first biosimilar pegfilgrastim approved in the United States, will be sold under the brand name Fulphila.

On June 1, drug maker Apotex announced that its Apobiologix division has received approval from Health Canada for its pegfilgrastim biosimilar, Lapelga. Lapelga is the first pegfilgrastim biosimilar to be approved in a highly regulated territory.

During the 2018 American Society of Clinical Oncology's Annual Meeting, researchers presented findings on 3 biosimilar trastuzumab products: Samsung Bioepis’ SB3, Agmen’s ABP 980, and Biocad’s Herticad.

Amgen has announced that the FDA has issued a Complete Response Letter for its biosimilar trastuzumab candidate, ABP 980.