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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.

Green Shield Canada (GSC), a not-for-profit health benefits company that offers employee group health benefits that supplement government-sponsored provincial health plans, has announced a new program to switch patients to biosimilar therapies.

Anti–tumor necrosis factor (anti-TNF) treatment has revolutionized the management of ankylosing spondylitis (AS), but 20% to 30% of patients discontinue treatment due to failure or inadequate response to treatment. That being said, anti-TNF therapies are structurally different and have different mechanisms of action; consequently, unsuccessful treatment with 1 anti-TNF drug does not determine a patient’s potential response to another.

Merck, operating under the trade name MSD in the European Union, announced today that it has launched Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, in the United Kingdom.

Gillian Woollett, MA, DPhil, senior vice president of Avalere and leader of the company’s FDA practice, told The Center for Biosimilars® in an interview that a study she co-authored is aimed at reassuring all biosimilar stakeholders that, “even though no clinical differences are expected when patients are switched from a reference product to a biosimilar, indeed none are found. Hence, we confirm the expectation already established through the application of sound regulatory science.”

The Complete Guide to Monoclonal Antibody and Granulocyte-Colony Stimulating Factor Biosimilars Approved in the United States and European Union

“You can’t have your cake—or in this case, your rebates—and a vibrant market for biosimilar competition too,” said FDA Commissioner Scott Gottlieb, MD.

A recent study analyzed the long-term efficacy and safety profile of anti–tumor necrosis factor (anti-TNF) treatment in 15 patients with rhupus, a rare association defined by the coexistence of both systemic lupus erythematosus and rheumatoid arthritis (RA) in the same patient.

Among commercial plans covering employees and their families, said Express Scripts, drug spending increased by just 1.5% per person, down from 3.8% in 2016. Calling this rate a “historic low,” Express Scripts said that this level of spending growth is the lowest that it has measured since 1993.

The trastuzumab biosimilar is priced 29.5% below the list price for the trastuzumab reference product, Herceptin.

To determine whether a course of 300 ug of filgrastim, administered daily for 2 days, achieves the same clinical outcomes that have been reported with the recommended dosage, and whether such a dose could provide cost savings, investigators from Marshall University performed a retrospective chart review to identify all patients at their institution with chemotherapy-induced neutropenia who were treated with 2 consecutive doses of 300 ug of filgrastim between September 2011 and September 2016.

The law, which was passed with broad bipartisan support in both the Michigan House and Senate, allows for biologics designated by the FDA as interchangeable to be substituted at pharmacies with appropriate communication of the substitution to both patients and physicians.

On March 2, UK Prime Minister Theresa May delivered a speech on the future of the United Kingdom’s relationship with the European Union, calling for the United Kingdom to remain a member of the European Medicines Agency (EMA), and saying that the United Kingdom could commit to abiding by the rules of the EMA and “making an appropriate financial contribution” to the agency.

In an effort to evaluate whether switching from a reference biologic to a biosimilar could lead to altered clinical outcomes—such as enhanced immunogenicity, compromised safety, or reduced efficacy—a research team, led by Hillel Cohen, PhD, conducted a systematic literature review of all available switching studies.