News

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 23.

As AbbVie’s best-selling Humira faces oncoming biosimilar competition, the drug maker is developing a new innovator product that could help it retain a hold on the market; new results from 3 phase 3 clinical trials show AbbVie’s investigational interleukin-23 inhibitor, risankizumab, to be more effective than adalimumab (Humira) or ustekinumab (Stelara) in patients with moderate-to-severe plaque psoriasis.

Russian biosimilar developer Biocad has won a legal battle that will allow it to move forward with its rituximab biosimilar.

This week, drug maker Sanofi filed a patent infringement suit against Mylan in a New Jersey district court. Sanofi’s suit alleges that Mylan has infringed on 18 patents for its originator insulin glargine, Lantus.

Advances in research suggest that neurotransmitters other than serotonin and noradrenaline may be involved in the pathogenesis and treatment of major depressive disorder, and have pointed to inflammation as an important factor.

Patients with rheumatoid arthritis (RA) have high healthcare utilization and high healthcare costs, which place a burden on health systems and patients alike. However, a recently published retrospective cohort study found that effective treatment for RA (namely, treatment with etanercept) may lead to lower overall and lower RA-related healthcare utilization.

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.