News

Today, Celltrion announced that the FDA has issued Complete Response Letters (CRLs) for 2 of its products, CT-P10, a proposed rituximab biosimilar referencing Rituxan, and CT-P6, a proposed trastuzumab biosimilar referencing Herceptin.

Data suggest that intravitreal bevacizumab increases the risk of thromboembolism, and some studies have raised the possibility of a link between bevacizumab and myocardial infarction (MI), while other studies did not find such a relationship.

In a briefing to regional committees, the United Kingdom's National Health Service (NHS) urged commissioners to begin planning to use the best-value adalimumab option beginning in October 2018, when Amgen’s EU-authorized biosimilar, Amgevita, becomes available.

Yesterday, the European Medicines Agency (EMA) opened a public consultation period concerning the European Union’s template for Good Manufacturing Practice (GMP) noncompliance statements. The EMA says that its GMP Inspectors Working Group is considering which actions will be required after an inspection concludes that a manufacturing site does not comply with GMP, especially in cases in which a statement of noncompliance could lead to a shortage of critical medicines.

A recent study provides the final long-term efficacy and safety results from the phase 3 ABILITY-1 trial’s open-label extension in patients with nonradiographic axial spondyloarthritis, which show that the anti–tumor necrosis factor agent adalimumab (Humira) provided sustained clinical and functional improvements through 3 years.

In the rule, CMS said that it would lower the maximum co-pay amount for low-income subsidy (LIS) beneficiaries for biosimilar and interchangeable biosimilars to match the lower co-pay amount required for generic and preferred multiple-source drugs.

Researchers found that peripheral injections of etanercept normalize the depressive effects of repeated steroid administration in an animal model.

The topic of interchangeability continues to draw debate when it comes to biosimilars, as perceptions on its value and market impact vary per stakeholder. Here are 9 things to consider when examining biosimilar interchangeability.

Last week, Senator Claire McCaskill, D-Missouri, together with the minority staff of the Senate Homeland Security and Government Affairs Committee (HSGAC), released a report on prescription drug price increases that affect the 20 products most commonly prescribed to seniors.

“A [3]-year time lag for the next biosimilar medicine, from market authorization to the patient switching process, should not occur," say the authors of a recent review.

In a recently published study, researchers sought to determine the cost effectiveness of bevacizumab in treating recurrent ovarian cancer from a Canadian public payer perspective.

In Pfenex’s fourth-quarter 2017 investor call, Evert Schimmelpennink, CEO, president, secretary, and director, hinted that Pfenex may be ready to resume work on 2 biosimilar candidates whose programs had been on hiatus.

Last week, Theradiag, a French company specializing in in vitro diagnostics and theranostics (targeted therapy based on findings in diagnostic tests) announced that it has entered a new partnership agreement with pharmaceutical group Biogaran.

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.