Kelly Davio

Universal access to affordable essential medicines remains an unmet goal, and while the World Health Organization has been attempting to address this problem through prequalification of drugs like insulin to help ensure access for patients in low-resource areas, costs for many products remain prohibitive.

Data on the safety and efficacy of biosimilar infliximab CT-P13 (Inflectra, Remsima) in treating inflammatory bowel disease (IBD) continue to accrue, in both adult patients and in pediatric patients, and a study from Finland adds to that body of knowledge, while another study in pediatric patients shows that Janus kinase (JAK) inhibitors may be an option for those who do not respond adequately to infliximab or other biologic treatment.

During November, biosimilar developers announced a spate of new business agreements and acquisitions. November also saw biosimilars approved and launched, and innovator products’ sales slipping.

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.

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The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins.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.

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.

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

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.

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.

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.

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.

While much attention over the past few weeks has been on the US biosimilars market, with its recent approvals and product launches, Canada has also been making strides in its own biosimilars experience.

The FDA has approved Pfizer’s adalimumab biosimilar, Abrilada (adalimumab-afzb), referencing Humira.

Novartis has confirmed in an email to The Center for Biosimilars® that it has launched Sandoz’s pegfilgrastim biosimilar, Ziextenzo, in the United States. According to Novartis, the wholesale acquisition cost (WAC) for Ziextenzo is $3925, or an approximate 37% discount off the WAC for the reference product, Amgen’s Neulasta.

The AARP Public Policy Institute has released a new Rx Price Watch report showing that, last year, the retail prices of 267 brand-name drugs that are commonly used by older Americans rose by an average of 5.8%—more than twice the general rate of inflation, which was 2.4%.

As the only anti–tumor necrosis factor therapies currently available to US patients with inflammatory diseases, biosimilars of infliximab are increasingly used to treat diseases like rheumatoid arthritis. While there are a wealth of data on real-world use of these products in territories like the European Union, less research has examined their use in the United States. During the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, researchers reported on the results of 3 studies that assessed real-world use of biosimilar infliximab in the US context.

While US patients continue to wait for a biosimilar etanercept to become commercially available, real-world data continue to amass for Samsung Bioepis’ biosimilar, SB4, in European clinical practice. The biosimilar, sold as Benepali in the European context, was the subject of several studies presented this week at the American College of Rheumatology’s 2019 meeting, held in Atlanta, Georgia.

Among the first biosimilars to gain US approval was Sandoz’s etanercept biosimilar, GP2015, or Erelzi. The product was authorized by the FDA in 2016, but it has not yet launched in the US market due to long-running patent disputes related to Amgen’s innovator product, Enbrel. In other markets, however, the biosimilar is a widely used treatment option, and data presented at the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, show that not only is the biosimilar safe and effective in real-world practice in ex-US markets, but it could also bring about substantial savings in the United States once it becomes available.

Improvements in biosimilars—ones that may give them an advantage such as lower immunogenicity or a new route of administration—may be the key to unlocking a better patient experience, according to Celltrion. In fact, pursuing such so-called “biobetters” may prove to be more important for the drug maker than pursuing interchangeable biosimilars.

During the FT Global Pharmaceutical and Biotechnology Conference, held this week in London, United Kingdom, a panel of executives from pharmaceutical companies, together with a scientist whose focus is on economics, discussed the increasingly challenging problem of paying for innovative therapies, particularly in a context of heightened political pressure around high drug costs.

Over the past few years, awareness of biosimilars has been increasing; however, research presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, shows that while US rheumatologists hold growing awareness of biosimilars, hesitancy remains around such issues as switching stable patients and the extrapolation of indications.

On Sunday, during the American College of Rheumatology (ACR)’s 2019 meeting, being held in Atlanta, Georgia, researchers reported on the safety and efficacy of the proposed infliximab biosimilar ABP 710 in a phase 3 study of patients with rheumatoid arthritis (RA). Researchers also reported on a phase 1 and 3 study of the proposed rituximab biosimilar, ABP 798, in patients with RA.

The great promise of biosimilars is their ability to provide high-quality treatment at a reduced cost, thereby producing cost savings that can be reapplied. But how are healthcare systems around the globe utilizing those cost savings? During the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting, held this week in Copenhagen, Denmark, several teams of researchers reported on how biosimilars are impacting international markets, and how they could provide headroom for new, expensive treatments.

Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11.

This week, multiple biosimilar developers announced major moves forward for their businesses, with Coherus BioSciences making a new acquisition, Celltrion reporting continued growth for its business, Bio-Thera Solutions gaining the first-ever approval of an adalimumab biosimilar from China’s National Medical Products Administration, and Alvotech and Stada entering into a 7-biosimilar partnership in Europe.

The FDA has issued an establishment inspection report (EIR) for Biocon’s Bengaluru facility, where the drug maker manufactures biosimilars, and the FDA’s inspection of the facility, which took place during August 2019, is now closed.