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A new paper argues that the addition of a single data element—namely, a batch or lot number—would enhance the value of pharmacovigilance systems for biosimilars.

As the treatment paradigm in inflammatory bowel disease (IBD) has shifted from controlling symptoms to fully controlling disease in order to prevent organ damage and disability, some have argued that disability is a better, more objective measure than quality of life in clinical trials and population studies of IBD.

In 2008, tbo-filgrastim (Granix) was approved as a biosimilar in Europe. In 2012, it was approved in the United States as a follow-on biologic product to filgrastim. Tbo-filgrastim was less expensive than filgrastim, and clinical information and expert opinion supported similarity between the products. This led the pharmacy and therapeutics committee of a major US health system to approve tbo-filgrastim as the preferred granulocyte-colony stimulating factor (G-CSF) product in March 2014.

The Center for Biosimilars recaps the most-read articles of 2017.

Adalimumab demonstrated efficacy and safety in the treatment of patients with moderate to severe ulcerative colitis (UC) in the first Brazilian study to demonstrate the effectiveness and safety profile of the therapy in patients with UC.

Elan Rubinstein, PharmD, MPH, voiced his frustration with the lack of presence the pharmacy profession has had in the negotiations of repealing and replacing the Affordable Care Act.

While 2017 was a busy year for biosimilar approvals by the FDA, Rick Lozano, vice president of biosimilars and integrated business development at AmerisourceBergen, feels that the biggest developments in biosimilars were those being made outside the regulatory or clinical spheres. In an interview with The Center for Biosimilars®, Lozano said that “There are distractions and defense strategies in the market that continue to be slowing the pace” of bringing biosimilars to the market.

Antidrug antibodies (ADAs) are commonly found in healthy subjects after a single intravenous dose of infliximab and result in faster clearance of infliximab, shorter elimination time, and lower serum infliximab levels, according to a study published in the September 2017 issue of Drugs in R&D by Eli D. Ehrenpreis, MD.

The Center for Biosimilars recounts 4 of the top legal developments in the biosimilars space during 2017.

In clinical practice, biologics are routinely used for medically accepted off-label indications, and these uses are typically curated by guidelines. A newly published study, led by Edward Li, PharmD, MPH, BCOP, argues that the FDA’s framework for granting the extrapolation of indications for biosimilars can be used by clinicians and payers to determine appropriate off-label uses of biosimilars.

Biosimilar drugs significantly influence the reimbursement systems of 10 Central and Eastern European countries, and the expenditure on the reimbursement of biosimilars (percentage of drug price covered by public payers) in those countries is increasing as biosimilars become more accessible to patients.

A recently published review appearing in the International Journal of Molecular Sciences, looks at the factors influencing psoriasis severity and the indications for systematic treatments.

According to Marcus Snow, MD, assistant professor of internal medicine in the division of rheumatology, University of Nebraska Medical Center, some of the most critical developments in the biosimilars space during 2017 were the result of payer decisions.

A Polish study of axial spondyloarthritis patients who discontinued treatment with anti–tumor necrosis factor (anti-TNF) therapy because of low disease activity found that more than half eventually needed to restart anti-TNF therapy.

2017 brought a number of notable guests to The Center for Biosimilars®. Here are the most-watched interviews of the year.

While more biosimilars gained regulatory approval 2017 and neared their entry into the US marketplace, physician acceptance of these products proved to be a challenge.

The United States now has 9 FDA-approved biosimilars. Our latest infographic breaks down what you need to know about these products.

The European risk management plan (RMP) contains relevant safety information for specific products, with characterizations of both potential and identified risks, including real-world data. Because the RMP is systematically updated, the RMP can provide early indications of differences in product safety between originator and biosimilar therapies.

The Center for Biosimilars recaps the the top 5 articles for the week of December 18, 2017.

The US Government Accountability Office (GAO) reports that retail drug spending accounted for about 12% of total personal healthcare service spending in the United States in 2015, up from about 7% through the 1990s.

Developments at the FDA and greater physician acceptance of biosimilars made 2017 a banner year for emerging therapies, according to James Stevenson, PharmD, FASHP, professor of clinical pharmacy at the University of Michigan College of Pharmacy.

Biologics are the most expensive drug category in the United States. A recent study, published in the Journal of Managed Care and Specialty Pharmacy, investigated how American health systems are reacting to the introduction of biosimilars into the marketplace, and described real-world implementation strategies.

Biologic drugs play a key role in the US healthcare market, as they are often the standard of care for treating complex diseases, many of which require long-term treatment. With the FDA’s approval of biosimilars of several important biologic treatments, and with a significant pipeline of biosimilars still in development, it is expected that many biosimilars will be introduced to the US market in the next several years.

JHL Biotech, a biopharmaceutical startup based in Taiwan, announced yesterday that it has submitted a phase 1 clinical trial application to the Dutch Healthcare Authority for its proposed dornase alfa biosimilar, JHL1922, to improve pulmonary function in patients with cystic fibrosis.

On December 19, Richard Seeborg, US district judge for the Northern District of California, granted a summary judgment of noninfringement in Amgen v Sandoz.

AbbVie reported on Wednesday that a phase 3 trial of its upadacitinib as monotherapy for rheumatoid arthritis (RA) met all of its primary and key secondary endpoints, giving more momentum to the drug that appears poised to help AbbVie retain its share of the RA market after adalimumab biosimilars launch in the United States. However, a death reported during the trial raises renewed concerns about the safety of the Janus kinase inhibitor.

Tax disclosure forms for 2016 show that the pharmaceutical industry’s biggest trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), raised revenue by almost one-fourth and spent the millions collected among hundreds of lobbyists, politicians, and patient groups—the largest income surge reported by the group since 2009, when it was mobilizing forces to advance the industry’s interests prior to the passage of the Affordable Care Act.

Hikma Pharmaceuticals Plc. announced yesterday that it has reached a licensing agreement with Republic of Korea-based Celltrion for its rituximab biosimilar, Truxima, referenced on MabThera.

Last week’s ruling in the federal circuit, which held that state law cannot compel biosimilar applicants to participate in the Biologics Price Competition and Innovation Act (BPCIA) “patent dance,” has raised questions about how the case will impact the BPCIA in the days ahead. Yet Kevin M. Nelson, JD, partner at Schiff Hardin’s Hatch-Waxman and biosimilars practice, told The Center for Biosimilars® in an interview, that, “For the BPCIA, I don’t think it means much.” In Nelson’s view, the most significant impact that the ruling will have is on the early case assessments that biosimilar applicants undertake when determining whether they will take part in the information exchange process.

Republic of Korea-based Samsung Bioepis announced on Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB3, a proposed trastuzumab biosimilar, referenced on Herceptin. If the FDA approves SB3, the drug will be commercialized in the US by Merck.