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The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of March 26, 2018.

Walmart is reportedly in early talks with Humana; Aetna says that it will automatically apply pharmacy rebates at the time of drug sales for its fully insured commercial plan members; and the American Antitrust Institute is raising concerns about 2 proposed acquisitions.

March 2018 saw a variety of developments for biosimilars in cancer care, both in the United States and abroad.

Eflapegrastim is novel long-acting granulocyte-colony stimulating factor therapy. Pharmacokinetic analysis in vivo demonstrated a 2- to 3-fold increase in area under the time‐concentration curve for absolute neutrophil count versus pegfilgrastim when administered at similar doses, and the proposed drug demonstrated comparable efficacy compared with pegfilgrastim in an open-label study in patients with breast cancer who were receiving docetaxel and cyclophosphamide.

One of the more serious concerns the FDA has discussed is the possibility that a developer of a proposed biosimilar could be deterred from seeking approval of its product, because United States Pharmacopeial Convention's (USP) proposed changes could complicate the licensure of a proposed biosimilar that meets the approval requirements of the FDA but does not match the USP’s standards of a monograph.

On Monday, March 26, a Delaware court judge granted Coherus Biosciences’ motion to dismiss a lawsuit brought by Amgen over alleged infringement of a patent covering pegfilgrastim (Neulasta).

FDA Commissioner Scott Gottlieb, MD, indicated that the agency would be putting forward policies that would compel branded drug makers to “tighten up their manufacturing, to have less variance of their biologics that are currently on the market.” In theory, this change could make it easier to develop a biosimilar using smaller studies.

Last week, an overview of systematic reviews and meta-analyses investigating systemic adverse events associated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatments was published in JAMA Ophthalmology.

A new brief from Avalere Health argues that, if a multisource market for biologic drugs is to emerge in the United States, originator biologics and biosimilars must be able to gain market share commensurate to the value they offer to the healthcare system, and a variety of policy options are available to create the necessary conditions for true competition.

The biosimilar insulin will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen presentation in both territories. Mylan and Biocon say that they plans to launch the product in various markets in Europe in the second half of 2018, and in Australia “later this year.”

Within the juvenile idiopathic arthritis subset, “patients had an extremely favorable probability of being neoplasm-free 5 years after initiation of biologics.”

UK Prime Minister Theresa May has called for the United Kingdom to remain a member of the European Medicines Agency (EMA), but the European Council says that "The Union will preserve its autonomy as regards its decision-making, which excludes participation of the United Kingdom as a third-country to EU Institutions."

If the commentary we offer to improve the poor comprehension about biosimilars itself contains errors or a limited appreciation of the approval framework, the task of creating a stable and competitive market to reduce pharmaceutical expenses becomes that much more difficult.

While biosimilars have made significant inroads into the European marketplace, there remain hurdles to the adoption of these lower-cost drugs, especially in lower-income nations; external reference pricing can mean that drugs are priced to wealthier European countries’ financial capabilities, and manufacturers’ launch strategies may bring biosimilars to nations with the greatest market potential first.

Intravenous infusion therapy has become critical for the treatment and maintenance of many pediatric rheumatic diseases, such as juvenile idiopathic arthritis, systemic lupus erythematosus, and inflammatory bowel disease-associated arthritis. Recently, researchers conducted a retrospective review of all pediatric patients given infusions at the University of Alabama at Birmingham from 2012 to 2015.

Approximately 80% of Americans think that the cost of prescription drugs is unreasonable, and 73% believe that pharmaceutical companies are making too much profit on their products.

During a symposium held during the 23rd annual conference of the National Comprehensive Cancer Network (NCCN), held last week in Orlando, Florida, Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center; Jeffrey Crawford, MD, of Duke University; and Lee Schwartzberg, MD, FACP, of University of Tennessee Health Science Center, presented on the use of biosimilars in oncology.

Amgen and its partner Allergan announced Friday that their ABP 980, a trastuzumab biosimilar referencing Herceptin, has gained a positive opinion for marketing from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Earlier this week, President Donald Trump made a speech in New Hampshire to discuss the administration’s efforts in combatting both the opioid crisis and high drug prices. In the speech, Trump alluded to a possible press conference in the near future that would discuss potential proposals in reducing prescription drug prices.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of March 19, 2018.

Novartis division Sandoz announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the marketing authorization of biosimilar infliximab.

Rituximab induction therapy has the highest probability of cost effectiveness in treating newly diagnosed patients with asymptomatic advanced follicular lymphoma, according to a study published in the British Journal of Haematology.

Insurance lobbying group, America’s Health Insurance Plans (AHIP), recently named Matt Eyles as its next president and CEO beginning June 1. Eyles, currently AHIP’s chief operating officer, recently gave a statement about his priorities for the organization once he begins his tenure.

More than 90% of Indian patients with diffuse large B-cell lymphoma (DLBCL) treated from 2014 to 2015 had access to rituximab due to the biosimilar’s availability.

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.