News

A phase 3 trial of SB5, a proposed biosimilar to adalimumab (AbbVie’s Humira), showed that SB5 was equivalent to its reference with respect to the American College of Rheumatology's 20% improvement criteria (ACR20).

A newly published study evaluating LG Chem's proposed biosimilar etanercept in comparison with its reference (Enbrel) found that LBEC0101 had equivalent clinical efficacy and a comparable safety profile to the reference etanercept, and that the proposed biosimilar was well tolerated.

Republic of Korea–based drug developer Polus has sold $9.37 million in convertible bonds to its affiliate Amnis.

The Psoriasis Stratification to Optimize Relevant Therapy (PSORT) study assessed real-world levels of self-reported non-adherence to traditional systemic and biologic therapies used for psoriasis, and evaluated psychological and biomedical factors associated with non-adherence using multivariable analyses.

Mylan and Biocon ended 2017 with more positive news for their biosimilar program; on December 29, 2017, the partnership announced that Brazil’s National Sanitary Surveillance Agency (ANVISA) had approved their trastuzumab biosimilar.

Bevacizumab is employed cautiously in patients with multifocal glioblastomas rather than single glioblastomas because of a fear, based on unconfirmed preclinical data, that bevacizumab can increase the invasive tumor phenotype.

There are a variety of biologics available for the treatment of psoriasis; our latest infographic provides examples of each type.

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.