News

More than 90% of Americans believe that the cost burden of cancer is too high, according to a large, nationally representative survey conducted for the American Society of Clinical Oncology (ASCO).

The high cost of prescription drugs, the need for more competition in the marketplace, and the potential for biosimilars to provide substantial savings were key topics among biosimilars stakeholders in the month of October.

New data show that switching patients with Crohn’s disease to CT-P13 from the reference infliximab led to comparable efficacy, safety, and tolerability between the 2 treatments over a 24-week period. The full 54-week results of the phase 3 study support the long-term effectiveness of treatment with CT-P13, the researchers say.

A recent study found that injectable anticancer drugs steadily increase in price, even after competition enters the market.

The biologic has the potential to deliver effective treatment for adult patients with generalized myasthenia gravis, but it comes at a high cost.

CVS Health is considering a possible $66 billion takeover of Aetna, and Amazon appears to be positioning itself for possible development as a PBM.

Sandoz announced today that its biosimilar pegfilgrastim has been accepted for review by the European Medicines Agency (EMA).

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.