Business

Amazon Business has hit pause on its plan to sell and distribute pharmaceutical products to hospitals after investigating the possibility last year.

Last week, a federal appeals court in Maryland ruled that a law, passed in 2017 and aimed at combatting increases in the price of generic medicines, is unconstitutional.

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.”

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.

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.

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.

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.

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.

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.

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.

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.”

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.

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.

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.