News

In patients with IBD, it was found that gut microbial levels lack in diversity. After receiving infliximab treatment, CD patients restored their microbial diversity and increased their Clostridiales levels. Clostridiales reduced proinflammatory bacteria, produced short-chain fatty acids, and induced an immune response.

One week after intravitreal bevacizumab injection, corneal endothelial cells showed no sign of inflammation or any other complications, according to a study published in BMC Ophthalmology.

In an interview with The Center for Biosimilars®, Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology (ACR) Government Affairs Committee, discussed the letter recently sent to HHS addressing physician concerns with proposed legislation.

Although corticosteroids are a mainstay of treatment for immune reconstitution inflammatory syndrome (IRIS), some patients with HIV are refractory to corticosteroid therapy. Infliximab may be useful in treating IRIS, but little is known about patients who are also refractory to infliximab therapy.

South Korean-based drug manufacturer, Celltrion, has granted exclusive distribution rights of its trastuzumab biosimilar, Herzuma, to the Mundipharma global network of independent associated companies.

The FDA’s Center for Drug Evaluation and Research has launched its pilot to publicly release clinical study report (CSR) data from pivotal clinical trials as part of a greater push for agency transparency in the approval of new drugs.

Under the original proposed formulary change, adult patients currently taking the reference infliximab would be switched to the biosimilar.

A multi-center retrospective study of Japanese patients, newly published in PLOS One, sought to describe treatment persistence and reasons for discontinuation among patients who were treating their rheumatoid arthritis with 1 of 7 biologic agents: adalimumab, etanercept, infliximab, golimumab, certolizumab pegol, tocilizumab, and abatacept.

Korea's Ministry of Food and Drug Safety granted marketing approval to the biosimilar on March 17, to be sold as Eucept.

House Bill 4005 requires drug manufacturers to compile a report on a prescription drug if the price was $100 or more for a 1-month supply (or course of treatment lasting less than 1 month) and if the net price increased by 10% or more.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of March 12, 2018.

This week, the Spanish Society of Digestive Pathology (SEPD) became the most recent organization to announce an updated position statement on the use of biosimilars.

Biosimilars of eculizumab, which have the potential to reduce costs for both patients and the healthcare system, have been eagerly awaited, yet many drug makers are developing novel anti-C5 agents.

Yesterday, 9 physician groups sent a joint letter to HHS Secretary Alex Azar in which they voiced concerns about the President’s 2019 Budget and the Council of Economic Advisers’ drug plan.

Data on the use of rituximab in treating patients with systemic lupus erythematosus (SLE) has been far from clear; 2 randomized controlled trials of rituximab in patients with SLE failed to meet their primary endpoints, while open-label trials have reported the drug’s efficacy in this indication.

This week, Israel-based Protalix BioTherapeutics, Inc, announced positive results from a phase 2 clinical trial for its orally administered anti–tumor necrosis factor (anti-TNF) drug, OPRX-106, a plant cell–expressed recombinant human TNF receptor II fused to an IgG1 Fc domain.

For 4 drugs—Crestor, Lantus, Advair, and Humira—the United States had higher prices than did any other nation—even more than double the next highest price.

Between 2013 to 2015, doctors at St. Petersburg City Hospital 15 wrote out prescriptions for 34 packages of the 500-mg dose and 31 packages of 100-mg dose, and the suspects allegedly then sold the stolen drugs for a total of around $51,000.

Patients without comorbidities who received subcutaneous trastuzumab with their chemotherapy and endocrine therapy showed a significant improvement in emotional function, and reported that they were less upset by hair loss than the patients in the control group.

The IQVIA Institute for Human Data Science (formerly the IMS institute) has released a new report making predictions for the healthcare landscape in 2018 and beyond, and the report’s authors see biosimilars as having a key role in developed markets in the years ahead.

The biosimilar was developed by Dr Reddy’s Laboratories and first approved in India in 2007. A collaboration was announced in 2016 of Dr Reddy’s and TRPharm, under which TRPharm will register and commercialize a total of 3 biosimilar products of Dr Reddy’s in Turkey.

Randomized controlled trials have established the clinical efficacy and safety of infliximab in treating fistulizing Crohn disease (CD), and while evidence for adalimumab and vedolizumab in this indication is weaker, these drugs are also used in clinical practice, sometimes in treatment sequences of biologics, to treat fistulizing CD. In Europe, where access to biologic drugs is largely driven by budgetary considerations, biosimilars have the potential to improve access to treatment.

Coherus has announced that it sees the potential for a mid-year launch of its pegfilgrastim biosimilar.

The number of patent settlements that limit generic drugs' market entry and involve a transfer of value (monetary or otherwise) for the delay of entry have stabilized at a low level, says the European Commission.

The study concludes that the VOLTAIRE-RA study showed that the biosimilar Cyltezo and reference Humira are highly similar, and that switching from the reference to the biosimilar had no impact on efficacy, safety, or immunogenicity.

"The pharmacist remains a very important member of the healthcare team that has the ability to explain to the patient the differences between the biologic and the biosimilar. It is the pharmacist–patient relationship that will assist the patient in making the best decisions to obtain the optimal clinical outcome," said Larry D. Wagenknecht, PharmD, FMPA, FAPhA, CEO of the Michigan Pharmacists Association.

This week, Senators Tom Cotton, R-Arkansas, and Claire McCaskill, D-Missouri introduced the Preserving Access to Cost-Effective Drugs (PACED) Act in response to Allergan’s recent transfer of its patents covering its dry-eye drug, Restasis, to the Saint Regis Mohawk Tribe in exchange for the Tribe’s invocation of sovereign immunity against inter partes review.

The top 3 pharmacy benefit managers by market share will now be owned by insurers, whereas a year ago, only 1 was.

Not all stakeholders are convinced that UnitedHealthcare's newly announced change of policy is enough to offset the role that pharmacy benefit managers have had in rising out-of-pocket costs for consumers.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of March 5, 2018.