Kelly Davio

Chinese biologics developer Innovent has announced that its proposed bevacizumab candidate, IBI305, has met its primary end points in 2 randomized, head-to-head clinical trials that compared the biosimilar to the brand-name bevacizumab (Avastin).

On Tuesday, the FDA took significant steps toward a long-awaited transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars.

Since the advent of biosimilar filgrastim, patient access to the prophylaxis of chemotherapy-induced febrile neutropenia has improved in many regulatory territories, yet concerns remain about whether the United States is keeping pace with the rest of the world in biosimilar uptake and associated patient access.

Pfenex announced this week that it submitted to the FDA a New Drug Application (NDA) for its PF708, a teriparatide follow-on referencing Eli Lilly’s Forteo for the treatment of osteoporosis.

Samsung Bioepis has announced that a 1-year follow-up study comparing event-free survival in patients treated with SB3, a biosimilar trastuzumab (approved in Europe as Ontruzant) showed that the biosimilar has similar safety and efficacy profiles to the reference Herceptin.

A slowdown in overall spending was driven, in part, by reduced growth in spending on prescription drugs. In 2014, spending on these drugs grew by 12.4%; this pace saw just 0.4% growth in 2017.

After increased pressure on pharmacy benefit managers to remake their approaches to rebates, CVS Health has announced that it will offer a new prescription benefit option in 2019 that will pass all drug makers' rebates back to its plan clients.

The launch of biosimilar rituximab is an eagerly awaited event among US healthcare stakeholders who are cognizant of the high cost of intravenously (IV) administered rituximab in treating non-Hodgkin lymphoma (NHL). At the same time, another innovation in rituximab delivery—a subcutaneously administered rituximab formulation—has the potential to save both cost and time.

For health systems like the Veterans Health Administration (VHA), where controlling costs while providing high-quality care is of heightened concern, achieving the best value for money in the prophylaxis of neutropenia can help to control the cost of cancer care.

Celltrion’s CT-P10, a biosimilar rituximab that was FDA approved under the brand name Truxima in November 2018, is already in wide use for a host of indications in many regulatory territories. During this week’s 60th Annual Meeting and Exposition of the American Society of Hematology in San Diego, California, multiple research teams are reporting data that underscore the safety and efficacy of CT-P10 in hematological conditions.

The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA to clarify appropriate sponsor communications about biosimilars.

Patients who are candidates for hematopoietic stem cell transplantation (AHSCT) require adequate collection of stem cells, and granulocyte colony-stimulating factor agents (G-CSFs) are typically used for stem cell mobilization while plerixafor is used to increase the yield of mobilized stem cells. While the biosimilar filgrastim agent Zarxio has become a more widely used, cost-saving G-CSF option in this context, little research has been conducted on whether the use of the biosimilar rather than its reference, Neupogen, has an impact on plerixafor use in patients undergoing AHSCT.

During November 2018, biosimilar developers worldwide made tough choices about how to move forward with their products and pipelines.

JCR Pharmaceuticals announced yesterday that it has launched its biosimilar agalsidase beta product, referencing Fabrazyme, in Japan for the treatment of Fabry disease. JCR developed the drug in partnership with Amicus Therapeutics and GlaxoSmithKline.

A founding member of the Biosimilars Forum has withdrawn its membership from the organization. Amgen has confirmed to The Center for Biosimilars® that it gave up its membership in the group in September of this year.

The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs).

This month, the Court of Justice of the European Union ruled that Italy’s national health system can reimburse for the use of bevacizumab in the treatment of eye diseases, such as age-related macular degeneration, despite the fact that bevacizumab does not have a marketing authorization for this indication.

The Association of the British Pharmaceutical Industry, a trade group representing UK drug makers, announced that it has reached a voluntary deal with the UK government that involves capping the growth of sales of brand-name drugs to the National Health Service at 2% per year in exchange for faster product launches and speedier appraisals by the National Institute for Clinical Excellence (NICE).

The proposed rule would allow plans to make broader use of prior authorization and step therapy for drugs—including drugs in protected classes—that are covered under Part D.

This morning, the United Kingdom’s National Health Service (NHS) announced that it has completed negotiations over using the best-value adalimumab product, and it has arrived at a plan whereby it will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.

A recent study sought to clarify factors that could predict therapeutic response to infliximab in Japanese patients with Crohn disease (CD), and found 4 key indicators that may predict response in clinical practice.

Despite the extensive body of literature on rheumatoid arthritis (RA), the exact causes of the disease are not fully understood. Tumor necrosis factor alpha (TNF) is known to play a key role in the disease by stimulating catabolic processes and causing inflammation, and important elements of inflammation include changes in extracellular matrix compounds and their constituents, such as glycosaminoglycans.

Bevacizumab, an anti–vascular endothelial growth factor treatment for which 1 biosimilar has been approved to date, has been shown to improve quality of life for patients with glioblastoma—and to delay disease progression—but has not prolonged patients’ overall survival. However, recent research suggests that using 4 older drugs together with bevacizumab could provide a more effective treatment protocol.

While the United Kingdom (UK) was a slow adopter of biosimilars compared with many of its European counterparts, recent years have seen a steady uptick in biosimilar use. A new qualitative study, using semistructured interviews with healthcare providers in the United Kingdom’s West Midlands region, sought to assess attitudes toward biosimilars in the clinical specialties of diabetes, inflammatory bowel disease, and rheumatology.

Some studies have found that granulocyte colony-stimulating factor (G-CSF) therapies are underused for the prophylaxis of febrile neutropenia (FN) in Europe, but the widespread availability of cheaper biosimilar options has led to increased use. A new study, published in BMC Cancer, sought to examine the use of the biosimilar filgrastim, Zarzio, in relationship to European Organisation for Research and Treatment of Cancer (EORTC) guidelines.

Denmark’s national authorities have confirmed to The Center for Biosimilars® that AbbVie's Humira did not offer the lowest price for adalimumab in either of 2 national tenders.

In many regulatory territories, patients with Crohn disease (CD) who lose response to adalimumab at a dose of 40 mg given every other week may be given an escalation to 40 mg every week. However, in Japan, where adalimumab is typically administered by a healthcare provider rather than by the patient, a study investigated the efficacy, safety, and pharmacokinetics (PK) of adalimumab after a dose escalation to 80 mg every other week as a means to reduce the need for additional patient appointments.

During the 83rd Annual Scientific Meeting of the American College of Gastroenterology, researchers from the United Kingdom reported on yet another large, nonmedical switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), this time in the Pennine Acute Hospitals Trust.

During this week’s International Society for Pharmacoeconomics and Outcomes Research 2018 European meeting, the role of biosimilars in oncology is the subject of several research presentations, all of which underscore the importance of these agents in increasing patient access and driving down costs.

This week, healthcare economics stakeholders have gathered in Barcelona, Spain, for the 2018 annual European meeting of the International Society for Pharmacoeconomics and Outcomes Research. During the meeting, research teams from around the globe are presenting findings that support the use of biosimilar infliximab as a cost-saving measure.