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As nations around the world seek to reap the rewards of biosimilar savings, some countries, including Colombia, are updating their regulatory processes to better facilitate the introduction of biosimilars. A paper, recently published in the Generics and Biosimilars Initiative Journal, outlines the new landscape for biosimilar products in Colombia.

CVS Health announced earlier this week that it is taking action to combat high drug spending in a new comprehensive program aimed at helping patients save money on medications.

On Thursday, Leah Christl, PhD, director of the therapeutic biologics and biosimilars staff at the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs at the FDA, hosted the organization’s first “Ask Me Anything” session about biosimilars on the website Reddit. Christl responded to user questions about the biosimilar approval process, the differences between a biosimilar and an interchangeable product, and pricing.

This week, the American College of Rheumatology (ACR) raised concerns that CMS’ final 2019 Payment Notice Rule, which provides states with increased flexibility to determine which plan options they can select as Essential Health Benefit- (EHB) benchmark plans and select their own sets of benefits, could seriously jeopardize care for patients with inflammatory diseases.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 9, 2018.

Mylan's president, Rajiv Malik, said during the company's Investor Day, "If we don’t have a product and the market needs it, we’ll go and find it. Rituximab for Europe is a good example, we didn’t have it in the portfolio for either Biocon or Momenta, but we could find an opportunity…we’ll continue to do this; go out and keep on looking if there are gaps.”

In ongoing litigation over Celltrion and Pfizer’s infliximab biosimilar, Inflectra, a Massachusetts district court has granted Celltrion’s motion for leave to file a motion for summary judgment of non-infringement.

Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, told The Center for Biosimilars® in an interview that, as his practice has begun to implement the Oncology Care Model, it has moved 100% of its patients to biosimilar filgrastim, Zarxio, from the reference filgrastim, Neupogen.

AbbVie reports that the trial of 15 mg of orally-administered, once-daily upadacitinib met its primary endpoints, with 71% of patients achieving 20% improvement based on American College of Rheumatology criteria (ACR20), and 29% achieving clinical remission.

Researchers demonstrated that trastuzumab increased progression-free survival (PFS) in patients with uterine serous carcinoma.

The European Medicines Agency accepted for review a marketing authorization application for the proposed biosimilar, FKB327, in May 2017, and the companies say that they expect to receive the EMA’s decision during the second half of 2018.

In a press briefing today at Pfizer’s headquarters in New York, New York, Pfizer’s executives reviewed their progress with biosimilars to date and underscored the need for a level playing field if biosimilars are to compete with brand-name biologics in the United States.

Limited distribution networks, which are established when a drug maker contracts with either 1 or a limited number of distributors, can allow a manufacturer to efficiently manage the supply chain for a given product. However, as a recent paper argues, LDNs can have an anticompetitive impact on the marketplace.

In terms of the interactions with patient organizations, the code specifies that companies should not only respect the autonomy of patient organizations and their independence, but also ensure that support for patient advocacy organizations in the form of grants or charitable contributions not be conditional on promoting a specific medicine.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups overshadowed the total amount the companies spent on federal lobbying in 2015; of the 14 companies that contributed $116 million to advocacy groups, the same companies reported only about $63 million in lobbying activities for the same time period.

Sanofi’s list prices for Admelog are approximately 15% lower than the originator Humalog’s prices.

A recent study concludes that both hypertension and proteinuria, which are considered to be interrelated with the pharmacological action of bevacizumab, have the potential to indicate greater likelihood of therapeutic efficacy.

Forty percent of respondents had skipped a medical test or treatment to save on costs, and 32% had skipped filling a prescription (or took less medication than prescribed) because of costs.

Some industry groups have begun voicing their concerns that proposed tariffs could have a negative effect on the production of generics and biosimilars, and may increase the cost of these products.

The financial plan, which is revised each year, outlines the financial position of the Biosimilar User Fee Act program over the next 5-year authorization period, and explains how the FDA will allocate resources to build its biosimilars review program.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 2, 2018.

The respondents, from 95 countries and with interests in 73 specialties, discussed the performance of top pharmaceutical companies across key factors that influence corporate reputation.

Samsung Bioepis and Biogen announced today that the companies have reached a settlement with AbbVie, maker of the top-selling Humira, that will allow the partnership to launch their approved biosimilar—Imraldi—in the European Union on October 16, 2018.

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.