News

Legal challenges to a recent jury verdict in Amgen v Hospira continue, with both parties in the case filing briefs asking for new trials over aspects of the ruling.

A new report by the RAND Corporation estimates the potential future cost savings gained from the use of biosimilars in the United States at $54 billion over 10 years, and examines future policy issues surrounding this important market.

In its third-quarter earnings report, Swiss drug maker Novartis announced that its net sales have risen by 2%, and net income by 10%, compared to the same period last year. The company credited its biosimilars business as a key factor in its growth.

The FDA has released a new set of educational materials concerning the nature and the prescribing of biosimilar therapies.

Drug prices in several disease areas outpace other healthcare expenditures and result in inadequate availability of essential medicines globally, according to a recently published review.

A paper by Matti Aapro, MD, recently published in Supportive Cancer Care, outlined, for the first time, consensus recommendations on using pegfilgrastim in particular patients and therapeutic scenarios.

The Australian Medical Association has issued a comment to the nation’s government concerning new proposals aimed at increasing biosimilar uptake in Australia.

Data from 5 studies presented at the European Society for Medical Oncology (ESMO) 2017 meeting highlighted the progress of biosimilar trastuzumab candidates.

In addition to challenges related to reliable power, connectivity, transportation, and clean water, Puerto Rico

New data from an extension period of a phase 3 study of Samsung Bioepis’ SB2 (Renflexis) in patients with moderate to severe rheumatoid arthritis found that there was no clinically meaningful difference in safety, efficacy, or immunogenicity in patients who were switched from reference infliximab to the biosimilar compared with patients who continued treatment with either the reference or the biosimilar without switching.

The World Health Organization (WHO) has announced that, at present, it will not proceed with its proposal to use biological qualifiers (BQ) to assign international nonproprietary names to biosimilars.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of October 16.

SPCs are an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The goal of the SPC is to offset the loss of patent protection that occurs during the development and clinical trials of a generic or biosimilar.

A Dutch study reports that 24% of patients who switched from originator infliximab to CT-P13, an infliximab biosimilar, discontinued the biosimilar by their 6-month follow-up, mainly for reasons researchers termed “subjective” health complaints.

Rituximab, which is approved for the treatment of some cancers and inflammatory conditions, also holds significant promise for patients with neurological diseases.

While no one argues that orphan drugs that treat rare diseases can be expensive, the drugs’ reputation for being budget-busters is not borne out by a data presented in a recent report by Quintiles IMS Institute.

Nichi-Iko has disclosed that it is currently engaged in consultations with the FDA concerning the demonstration of interchangeability of its proposed biosimilar with the reference Remicade.

Health insurer Anthem has announced that it will launch its own pharmacy benefit management (PBM) company, IngenioRx, that will operate in partnership with CVS Health, in 2020.

On Monday, a Federal Circuit judge invalidated Allergan’s patents for its dry-eye drug, Restasis, on the basis of obviousness. He also ordered the joinder of the Saint Regis Mohawk Tribe with Allergan as a co-plaintiff in the action against drug maker Teva, which seeks to develop a follow-on version of the drug.

Switching patients from originator biologics to biosimilars is associated with the potential for a “nocebo” effect, a phenomenon that occurs when a patient’s negative expectation causes a treatment to have a more negative effect than it otherwise would—essentially, the opposite of the placebo effect.

A study newly published in the Journal of Clinical Oncology found that, regardless of competition or additional approved indications, injectable anticancer drugs are subject to steady increases in price after launch.

The Senate’s Health, Education, Labor and Pensions (HELP) Committee today heard testimony from pharmaceutical manufacturers and the supply chain in a full committee hearing titled “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay.”

Anti–tumor necrosis factor drugs are expensive, and there are a limited number of choices for IBD treatment, highlighting the need to use every existing agent optimally.

A newly published study found that the prevalence of T helper (Th) lymphocytes, specifically Th9 cells, is higher in patients who have rheumatoid arthritis, and that these cells may also be involved in immune responses against reference infliximab.

In an ongoing litigation over biosimilar adalimumab, AbbVie, maker of the blockbuster reference adalimumab (Humira), denied biosimilar developer Boehringer Ingelheim’s claims that the company has been padding its patent estate with overlapping patents in an effort to protect its drug from competition.

Because Medicare will be such a large payer for biosimilars, coding and payment policy set forth by CMS will have a significant effect on the success, sustainability, and availability of these lower-cost alternative products.

Who will be the first manufacturer to succeed in gaining European or United States regulatory approval for a biosimilar pegfilgrastim product?

Drug manufacturer JCR announced last month that it has submitted a marketing approval in Japan for JR-051, a proposed agalsidase beta biosimilar referenced on Fabrazyme.

In recent paper published in Rheumatology, authors Till Uhlig, MD, and Guro L. Goll, PhD explore some of the remaining barriers to the adoption of biosimilar therapies in Europe. Physician attitudes, patient concerns, and prescribing restrictions on biologic therapies are all identified in the paper as having a role curbing uptake of biosimilars.

Pharmaceutical manufacturers often pay significant rebates on brand-name medications to pharmacy benefit managers or health plans to reduce the cost of pharmacy benefits and promote their brand-name drugs. Traditionally, these rebates have been provided to payers—not to health plan members.