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The Center for Biosimilars® recaps the top stories for the week of November 25, 2019.

Researchers have hypothesized that signaling through the vascular endothelial growth factor (VEGF) pathway could have immunomodulatory effects, and a recent study reports on a phase 2 trial that assessed a combination of the immune checkpoint inhibitor nivolumab with the anti-VEGF agent bevacizumab, which now has a commercially available biosimilar.

The fact that biologic drugs are typically infused or injected poses numerous challenges, including discomfort for patients, instability under some storage conditions, and the generation of needle waste. Researchers have long sought a way to deliver biologics orally, and some teams have even reported progress toward the goal of delivering monoclonal antibodies in coated tablet forms. Now, researchers have reported in Nature Medicine that a luminal unfolding microneedle injector could be a feasible delivery device for biologic drugs like insulin.

Biocon announced today that its supplemental Biologics License Application (sBLA) for its biosimilar pegfilgrastim, Fulphila, filed with partner Mylan, has been approved by the FDA.

Coherus BioSciences and Amgen have reportedly settled a patent lawsuit over biosimilar adalimumab.

The draft guidance on clinical immunogenicity testing for insulin products is indeed a historic event: a bold step by the FDA that shows a determination that there is a need to bring into market lower-cost alternates to the reference products if the clinical studies that contribute to the majority of cost and time are not required.

A recent study assessed tofacitinib versus anti–tumor necrosis factor (anti-TNF) agents using data from the Corrona registry, a large, prospective, observational database of patients with rheumatoid arthritis (RA) in more than 174 practices in 41 US states.

The issue of whether to switch patients currently taking biologics to biosimilars has been playing out in Canada over the past week, as mandated switching begins in British Columbia, while a reference product maker fights against a possible similar change in 2 other provinces.

Because stand-alone pharmacokinetic (PK) studies are usually designed to focus on intrinsic and extrinsic factors that have a high potential to affect drug exposure, they leave other possible interactions unstudied; population PK (popPK) analysis allows for an assessment of multiple factors that are not otherwise evaluated in healthy volunteers and allows for a larger number of individuals to be included.

Celltrion Healthcare announced that the European Commission has authorized Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis. The product is the first subcutaneous infliximab option to be approved in any regulatory territory.

The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins. The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.

How much does the price of common drugs vary across the globe? A UK digital healthcare startup collected that information to display the disparities across 50 countries for 13 often-used pharmaceuticals, including adalimumab and insulin glargine.

Nordic countries have had some of the highest rates of biosimilar use, and extensive registry data in these countries also allow for observational studies of biosimilar use in real-world clinical practice. A new study used data from 5 such registries—which included more than 2000 patients with spondyloarthritis—to assess retention rates for those treated with biosimilars or reference products of etanercept and infliximab.

During the European Society for Medical Oncology Asia Congress 2019, held last week in Singapore, a research team led by Binghe Xu, MD, PhD, department of medical oncology at the Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China, reported that the biosimilar met its primary end point of best overall response rate at week 24.

Based on the number of bills coming through Congress, it is clear that biosimilars have become synonymous with decreasing healthcare costs. Even with only a few biosimilars commercially available thus far, the federal push towards these drugs has been pronounced.

Roche’s Japan-based subsidiary, Chugai Pharmaceutical, has filed a new patent infringement suit against Alexion in the District Court of Delaware.

The American Medical Association (AMA) wants medical schools and residency programs to start training medical students and residents in healthcare economics.

The potential and promise of biosimilars are there—it is up to all of us to bring it to reality so we can expand access to safe, effective, affordable drugs for women.

In an interview with The Center for Biosimilars®, Sandoz’s Sheila Frame, MBA, vice president of marketing, market access, and patient services, and William Yoon, PharmD, MBA, head of external engagement and medical advocacy, reflected on the past decade of experience with the biosimilar pathway and gave a look at the future of Sandoz’s biosimilar efforts.

The Center for Biosimilars® recaps the top stories for the week of November 18, 2019.

President Trump’s choice to lead the FDA faced some questions, but not many, about drug pricing, according to various press reports about the Senate committee hearing Thursday regarding the nomination of Stephen Hahn, MD, FASTRO, the chief medical officer of MD Anderson Cancer Center.

Last month, writing in a perspective piece in Clinical Pharmacology and Therapeutics, a group of authors further explored the rationale for developing and using pharmacodynamic (PD) biomarkers in biosimilar development.

On Monday, Polpharma Biologics announced that it has randomized the first patients in its phase 3 study of PB006, a proposed natalizumab biosimilar, and patients have begun to receive the study medication.

Perhaps not surprisingly, officials from generic drug companies, reference product companies, the FDA, and the Federal Trade Commission (FTC) have different opinions about the usefulness of various actions the federal government has taken to prevent abuses of risk evaluation and mitigation strategies (REMS), according to a recently released Government Accounting Office (GAO) report.

This month, the European Commission’s Pharmaceutical Committee, part of the Health and Food Safety Directorate-General, updated EU member states as to the results of a targeted consultation it undertook in 2018 on a specific type of duplicate marketing authorization applications (MAAs) for originator biologics and their potential impact on biosimilars.

Biosimilar infliximab CT-P13 (Inflectra, Remsima) has been the subject of numerous studies since its authorization in multiple regulatory territories, and this month, data from the Korean College of Rheumatology Biologics (KOBIO) registry add to the growing body of knowledge about this biosimilar’s use in patients with rheumatoid arthritis in routine clinical practice.

With more choices available in 2020 for Medicare stand-alone Part D drug plans, beneficiaries should compare choices, especially if they are not low income or on specialty drugs or drugs not on the payer’s formulary, according to a new analysis.

This week, a study from Spain retrospectively compared direct costs of intravenous and subcutaneous reference rituximab in the setting of lymphoma, taking into consideration drug costs, pharmacy costs, and chair time-related costs at a single center in 2017. They also conducted the same analysis using the costs of biosimilar rituximab.

Samsung Bioepis announced Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB8, a proposed bevacizumab biosimilar referencing Avastin. The biosimilar developer submitted the BLA in September.

A recent review explored the evidence of monoclonal antibodies (mAb) and fusion proteins (FP) to examine their safety and efficacy in the most common chronic inflammatory diseases in children—bronchial asthma, psoriasis, juvenile idiopathic arthritis (JIA), and chronic inflammatory bowel diseases (IBD).