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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.

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.

Under the original proposed formulary change, adult patients currently taking the reference infliximab would be switched to the biosimilar.

Korea's Ministry of Food and Drug Safety granted marketing approval to the biosimilar on March 17, to be sold as Eucept.

House Bill 4005 requires drug manufacturers to compile a report on a prescription drug if the price was $100 or more for a 1-month supply (or course of treatment lasting less than 1 month) and if the net price increased by 10% or more.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of March 12, 2018.

Biosimilars of eculizumab, which have the potential to reduce costs for both patients and the healthcare system, have been eagerly awaited, yet many drug makers are developing novel anti-C5 agents.

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.

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.

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.

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.

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.

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.